Source: https://www.scribd.com/document/107064947/Usp-35-Nf-30-General-Notices
Timestamp: 2019-01-21 12:54:03
Document Index: 632785988

Matched Legal Cases: ['§ 299', '§ 501', '§ 299', '§ 502', '§ 501', '§ 403', '§ 1700', '§ 1700', '§ 1700', '§ 1473', '§ 1700']

Usp 35-Nf 30 General Notices | Filtration | Assay
Usp 35-Nf 30 General Notices
Uploaded by Manish Vashistha
Applying to Standards, Tests, Assays, and Other Specifications of the United States Pharmacopeia
1. Title and Revision . . . . . . . . . . . . . . . . . . . . . . . 3 2. Official Status and Legal Recognition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.10. Official Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2.20. Official Articles . . . . . . . . . . . . . . . . . . . . . . . . . 3 2.30. Legal Recognition . . . . . . . . . . . . . . . . . . . . . . . 3 3.10. Applicability of Standards . . . . . . . . . . . . . . . . . . 3 3.20. Indicating Conformance . . . . . . . . . . . . . . . . . . . 4 4.10. Monographs . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4.20. General Chapters . . . . . . . . . . . . . . . . . . . . . . . . 4 5.10. Molecular Formula . . . . . . . . . . . . 5.20. Added Substances, Excipients, and Ingredients . . . . . . . . . . . . . . . . . . . . 5.30. Description and Solubility . . . . . . . 5.40. Identity . . . . . . . . . . . . . . . . . . . . 5.50. Assay . . . . . . . . . . . . . . . . . . . . . 5.60. Impurities and Foreign Substances 5.70. Performance Tests . . . . . . . . . . . . 5.80. USP Reference Standards . . . . . . . . . . . . . . . . . .5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 .6 .6 .6 .6 .6 .6
6.80. Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7. Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.10. Interpretation of Requirements . . . . . . . . . . . . . . 8 7.20. Rounding Rules . . . . . . . . . . . . . . . . . . . . . . . . . 8 8.10. Abbreviations . . . . . . . . . . 8.20. About . . . . . . . . . . . . . . . 8.30. Alcohol Content . . . . . . . . 8.40. Atomic Weights . . . . . . . . 8.50. Blank Determinations . . . . 8.60. Concomitantly . . . . . . . . . 8.70. Desiccator . . . . . . . . . . . . 8.80. Logarithms . . . . . . . . . . . . 8.90. Microbial Strain . . . . . . . . 8.100. Negligible . . . . . . . . . . . . 8.110. NLT/NMT . . . . . . . . . . . . 8.120. Odor . . . . . . . . . . . . . . . 8.130. Percent . . . . . . . . . . . . . . 8.140. Percentage Concentrations 8.150. Pressure . . . . . . . . . . . . . 8.160. Reaction Time . . . . . . . . . 8.170. Specific Gravity . . . . . . . . 8.180. Temperatures . . . . . . . . . 8.190. Time . . . . . . . . . . . . . . . . 8.200. Transfer . . . . . . . . . . . . . . 8.210. Vacuum . . . . . . . . . . . . . 8.220. Vacuum Desiccator . . . . . 8.230. Water . . . . . . . . . . . . . . . 8.240. Weights and Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 .9 10 10 10 10
3. Conformance and Standards . . . . . . . . . . . 3
8. Terms and Definitions . . . . . . . . . . . . . . . . . . 9
4. Monographs and General Chapters . . . . 4
5. Monograph Components . . . . . . . . . . . . . . . 5
6. Testing Practices and Procedures . . . . . . 7
6.10. Safe Laboratory Practices . . . . . . . . . . . . 6.20. Automated Procedures . . . . . . . . . . . . . . 6.30. Alternative and Harmonized Methods and Procedures . . . . . . . . . . . . . . . . . . . . . . 6.40. Dried, Anhydrous, Ignited, or SolventFree Basis . . . . . . . . . . . . . . . . . . . . . . . 6.50. Preparation of Solutions . . . . . . . . . . . . . 6.60. Units Necessary to Complete a Test . . . . 6.70. Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 . . . . . .7 . . . . . .7 . . . . . . . . . . . . . . . . . . . . .7 .7 .7 .8
9. Prescribing and Dispensing . . . . . . . . . . . . 10
9.10 Use of Metric Units . . . . . . . . . . . . . . . . . . . . . . 10 9.20 Changes in Volume . . . . . . . . . . . . . . . . . . . . . . 10
. . . . . Packaging. . . . . . . . . . . . .50. . . . . .2 General Notices USP 35 10. . . . Storage and Labeling . Guidelines for Packaging and Storage Statements in USP–NF Monographs . . . . Containers . . 10 10. . . Preservation. . . . . . . . . . . . . . . . . . . . . .40. . . . . . . . . . . 12 10. . . . . . . 10 10. . . . . . . . . . . . . . . . . . . Storage Under Nonspecific Conditions . 13 10. . . . . . . . . . . . . . 10 . .30. . Labeling . . . . . . . .20. . . . . .10. 11 10. . Storage Temperature and Humidity . . . . . . . .
users should understand applicable laws and regulations. General chapters numbered from 1000 to 1999 are considered interpretive and are intended to provide information on. Thirty-Fifth Revision and the National Formulary. Although USP and NF are published under one cover and share these General Notices. Early adoption of revised standards is allowed. They are published on the USP website and generally are official immediately unless otherwise specified in the Revision Bulletin. 21 CFR § 299. with no further distinction. In addition. and any Supplement(s) thereto. OFFICIAL STATUS AND LEGAL RECOGNITION 2. Revision Bulletins are revisions to official text or postponements that require expedited publication. to avoid being deemed misbranded. FDCA § 501(b) and 21 CFR § 299. 2012. Interim Revision Announcements are revisions to USP and NF that are published on the USP website. the identity. Official articles include both official substances and official products. Errata are corrections to items erroneously published that have not received the approval of the Council of Experts and that do not reflect the official requirements.5(c). unless labeled to show all respects in which the drug differs. give definition to. The title specified in a monograph is the official title for such article. and purity of an article are determined by the official tests. Errata are effective upon publication. Regulatory authorities may enforce the standards presented in the USP and NF. in the General Notices. excipient. 2. quality. NF 30. or describe a particular subject. and these General Notices. or component of a finished device for which the monograph title includes no indication of the nature of the finished form. Thirtieth Edition. Official Articles An official article is an article that is recognized in USP or NF. and acceptance criteria. a monograph. both USP and NF are recognized as official compendia. to NF 30. A drug with a name recognized in USP–NF must comply with compendial identity standards or be deemed adulterated. This revision is official beginning May 1. whether or not the monograph explicitly states the difference. and Cosmetic Act (FDCA). Enforcement of USP standards is the responsibility of FDA and other government authorities in the U.20) compliance with the revised standard shall not preclude a finding or indication of conformance with USP official standards. TITLE AND REVISION The full title of this publication (consisting of three volumes and including its Supplements). quality. In the United States under the Federal Food.20.30. 2. supersede all earlier revisions. See FDCA § 502(g). but because recognition of the USP and NF may vary by country. general chapters. applicable general chapters. or finished device for which a monograph is provided. A dietary supplement represented as conforming to specifications in USP will be deemed a misbranded food if it fails to so conform. and the National Formulary. FDCA § 501(b) and 502(e)(3)(b). apply equally to print or electronic presentation of these contents. Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the “compendia”) and to all general chapters unless specifically stated otherwise. such drugs must also comply with compendial standards for strength. Where the terms “USP.10.” section 2. To avoid being deemed adulterated. Thirtieth Edition. Unless specifically exempted elsewhere in a compendium. unless otherwise specified. See FDCA § 403(s)(2)(D). General chapters numbered above 2000 apply only to articles that are intended for use as dietary ingredients and dietary supplements. procedures. or both. see “official date.10) but are not yet official (six months after publication. strength. and General Notices. An article is deemed to be recognized and included in a compendium when a monograph for the article is published in the compendium and an official date is generally or specifically assigned to the monograph. Where the requirements of an individual monograph differ from the General Notices or a general chapter.g. Other names considered to be synonyms of the official titles may not be used as substitutes for official titles.5(a&b). See. unless USP specifies . e. The same titles.” or “USP–NF” are used without further qualification during the period in which these compendia are official. and purity. dietary supplement. An official substance is a drug substance. 2. and elsewhere.USP 35 General Notices 3 GENERAL NOTICES AND REQUIREMENTS The General Notices and Requirements section (the General Notices) presents the basic assumptions. Supplements to USP and NF are published periodically. e. Interim Revision Announcements contain official revisions and their effective dates. whether incorporated in the monograph itself.” “NF. CONFORMANCE TO STANDARDS 3. other ingredient. dietary ingredient. and default conditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF). or a general chapter numbered below 1000. An official product is a drug product. and to USP 35–NF 30. they are separate compendia. Announcements of the availability of new USP Reference Standards and announcements of tests or procedures that are held in abeyance pending availability of required USP Reference Standards are also available on the “New Official Text” tab of USP’s website. 1. also FDA regulations. Interim Revision Announcements. Applicability of Standards Standards for an article recognized in a USP compendium are expressed in the article’s monograph. Official Text Official text is text contained in USP and NF.10. drugs recognized in USP–NF must also be packaged and labeled in compliance with compendial standards. compounded preparation.. 3. They contain no mandatory requirements applicable to any official article unless specifically referenced in General Notices. misbranded. Where revised standards for an existing article have been published as final approved “official text” (as approved in section 2. or in the applicable general chapters. the monograph requirements apply and supersede the requirements of the General Notices or the general chapter. including monographs.S. unless otherwise indicated in specific text. Legal Recognition The USP and NF are recognized in the laws and regulations of many countries throughout the world. Thirty-Fifth Revision. These titles may be abbreviated to USP 35.g. Drug.. is The Pharmacopeia of the United States of America. The United States Pharmacopeia. definitions. See. and Revision Bulletins. Revisions to official text are provided in Supplements. USP has no role in enforcement. they refer only to USP 35.
g. or where there is use of synonyms with the intent or effect of suggesting a significant degree of identity with the official title or name. The letters are not to be enclosed in any symbol such as a circle.. the article shall be designated by a name that is clearly distinguishing and differentiating from any name recognized in USP or NF. where standards for such ingredients exist (for dietary supplements. users may wish to ascertain functional equivalence or determine such characteristics before use. dietary supplements are prepared from ingredients that meet USP. and other users of USP–NF. 3. Frequency of testing and sampling are left to the preferences or direction of those performing compliance testing. At times. When the letters “USP. and/or acceptance criteria to be used and the required labeling. or extrapolations of results to larger populations. or excipient differs from the relevant USP or NF standard of strength. Monograph Components. or excipient may use the designation “USP” or “NF” in conjunction with its official title or elsewhere on the label only when (1) a monograph is provided in the specified compendium and (2) the article USP 35 complies with the identity prescribed in the specified compendium. MONOGRAPHS AND GENERAL CHAPTERS 4. drug substance. When a drug product. dietary supplement. buyers. and other requirements related to packaging. general chapter(s). substances may be used in dietary supplements if they have been shown to be of acceptable food grade quality using other suitable procedures. procedures. hydrates. some official substances may conform to the USP or NF standard but differ with regard to nonstandardized properties that are relevant to their use in specific preparations.10. strength. and acceptance criteria set forth in the relevant compendium.10.” or “USP–NF” are used on the label of an article to indicate compliance with compendial standards. dietary supplement. or excipient fails to comply with the identity prescribed in USP or NF or contains an added substance that interferes with the prescribed tests and procedures. square. quality. etc. and acceptance criteria that help ensure the identity.10. drug substance. Repeats. see section 3. The designation “USP–NF” may be used on the label of an article provided that the label also bears a statement such as “Meets NF standards as published by USP. Generally. replicates. Such alternatives may be presented for different polymorphic forms.” indicating the particular compendium to which the article purports to apply. Applicability of Standards to Medical Devices. or regulatory authorities. and/or acceptance criteria that reflect attributes of different manufacturers’ articles. the letters shall appear in conjunction with the official title of the article. compendial standards take on the character of statistical procedures. The manufacturer’s specifications. Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs. NF.20. Monographs indicate the tests. and General Notices apply at all times in the life of the article from production to expiration. the individual ingredient(s) may be designated as complying with USP or NF standards or being of USP or NF quality provided that the designation is limited to the individual ingredient(s) and does not suggest that the dietary supplement complies with USP standards.10. 3. drug substance. when stored as directed. procedures. Official products are prepared according to recognized principles of good manufacturing practice and from ingredients that meet USP or NF standards.10. A medical device. or purity. The designation “USP” or “NF” on the label may not and does not constitute an endorsement by USP and does not represent assurance by USP that the article is known to comply with the relevant standards. The specification consists of tests. any official article is expected to meet the compendial standards if tested. Where such standards do not exist. storage. However. are developed and followed to ensure that the article will comply with compendial standards until its expiration date. 4. and dissolution cases. Indicating Conformance A drug product. see section 5. component intended for a medical device. or ingredient or component of a medical device or dietary supplement may use the designation “USP” or “NF” in conjunction with its official title or elsewhere on the label only when (1) a monograph is provided in the specified compendium and (2) the article complies with the monograph standards and other applicable standards in the compendium. The standards in the relevant monograph. Because monographs may not provide standards for all relevant characteristics. statistical rejection of outliers. and Their Components and Ingredients An article recognized in USP or NF shall comply with the compendial standards if the article is a medical device. 4. For general requirements relating to specific monograph sections. and is labeled as conforming to the USP or NF. and good manufacturing practices generally (including. Quality by Design initiatives). but in all cases. Dietary Supplements.20). and purity of the article. statements about whether the compendial standard is met apply only to the units tested. The standards apply equally to articles bearing the official titles or names derived by transposition of the definitive words of official titles or transposition in the order of the names of two or more active ingredients in official titles.” “NF. impurities.. definition. If a dietary supplement does not comply with all applicable compendial requirements but contains one or more dietary ingredients or other ingredients that are recognized in USP or NF. Thus. procedures. multiple procedures may be included in particular monographs specifically for the purpose of assuring the availability of an appropriate procedure for a par- . and shall appear in capital letters. The applicable standard applies to such articles whether or not the added designation “USP” or “NF” is used.10. or other ingredient that is intended for incorporation into a dietary supplement. A test in a monograph may contain and require multiple procedures. The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units. dietary ingredient. as well as the necessity and appropriate frequency of batch testing. To assure interchangeability in such instances. with multiple units involved and perhaps a sequential procedural design to allow the user to determine that the tested article meets or does not meet the standard. Monographs Monographs set forth the article’s name. as determined by the application of the tests. 3.4 General Notices otherwise by prohibiting early adoption in a particular standard. and Excipients The applicable USP or NF standard applies to any article marketed in the United States that (1) is recognized in the compendium and (2) is intended or labeled for use as a drug or as an ingredient in a drug. specification. or Food Chemicals Codex standards. its difference shall be plainly stated on its label. including manufacturers.20. and labeling. e. procedures. and any official article actually tested as directed in the relevant monograph must meet such standards to demonstrate compliance. quality.10. USP may seek legal redress if an article purports to be or is represented as an official article in one of USP’s compendia and such claim is determined by USP not to be made in good faith. Drug Substances. When a drug product. Applicability of Test Procedures A single monograph may include several different tests. are neither specified nor proscribed by the compendia. Applicability of Standards to Drug Products.
helium. (See also Added Substances under Injections 〈1〉.20. Added Substances.20. preservatives. or safety of the official article.20.30. A labeling statement is not required if Test 1 is used. The reference table merely denotes the properties of articles that comply with monograph standards. Where a process is given in the individual monograph. • Descriptions and specifications of conditions and practices for pharmaceutical compounding. They may reference other general chapters that contain techniques. • Descriptions of general pharmaceutical storage. 5. An official product shall be formulated with the intent to provide 100 percent of the quantity of each ingredient declared on the label. Added Substances Added substances are presumed to be unsuitable for inclusion in an official article and therefore prohibited. therapeutic efficacy. acceptance criteria. and for deterioration to an extent considered acceptable under practical conditions. Added Substances.S.) The proportions of the substances constituting the base in ointment and suppository products and preparations may be varied to maintain a suitable consistency under different climatic conditions. the label shall indicate the name(s) and amount(s) of any added substance(s). The use of such gas need not be declared in the labeling. The existence of compendial acceptance criteria does not constitute a basis for a claim that an official substance that more nearly approaches 100 percent purity “exceeds” compendial quality. therapeutic efficacy. Deviation from the specified processes or methods of compounding. provided that the denaturant is volatile and does not remain in the finished product. The acceptance criteria specified in individual monographs and in the general chapters for compounded preparations are based on such attributes of quality as might be expected to characterize an article compounded from suitable bulk drug substances and ingredients. the fact that an article has been prepared to tighter criteria than those specified in the monograph does not constitute a basis for a claim that the article “exceeds” the compendial requirements. the ingredient need not be dried before use if due allowance is made for the water or other volatile substances present in the quantity taken. In Compounded Preparations Compounded preparations for which a complete composition is given shall contain only the ingredients named in the formulas unless specifically exempted herein or in the individual monograph. General Notices 5 5.20.20. carriers. or nitrogen.10. 5. a labeling statement to indicate the appropriate application of the procedure(s) will be included in the monograph. provided that the denaturant is either a usual ingredient in the preparation or a permissible added substance. Added substances and excipients employed solely to impart color may be incorporated into official products other than those intended for parenteral or ophthalmic use.20. and Ingredients in Official Substances Official substances may contain only the specific added substances that are permitted by the individual monograph. usefulness. in accordance with the regulations pertaining to the use of colors issued by the U. flavors. Where the minimum amount of a substance present in a dietary supplement is required by law to be higher than the lower acceptance criterion allowed for in the monograph. A preparation that is intended for topical application to the skin may contain specially denatured alcohol. Chromatography 〈621〉).10. Similarly. using the procedures provided or recognized principles of good compounding practice. Molecular Formula The use of the molecular formula for the active ingredient(s) named in defining the required strength of a compendial article is intended to designate the chemical entity or entities. provided that the concentrations of active ingredients are not varied and provided that the bioavailability. (2) their presence impairs the bioavailability. 5.20. pharmaceutical bases. the upper acceptance criterion contained in the monograph may be increased by a corresponding amount. or to facilitate its preparation. and vehicles may be added to an official product to enhance its stability. if: (1) they exceed the minimum quantity required for providing their intended effect. and packaging practices. MONOGRAPH COMPONENTS 5. 4. In Dietary Supplements Additional ingredients may be added to dietary supplement products provided that the additional ingredients: (1) comply with applicable regulatory requirements. argon. be evacuated or be replaced by carbon dioxide. stabilizers. Where such addition is permitted. and (2) do not interfere with the assays and tests prescribed for determining compliance with compendial standards.g. unless otherwise specified in the individual monograph. or by a mixture of these gases. dispensing.USP 35 ticular product. In such cases. 5. A monograph may include information regarding the article’s description. Specially denatured alcohol formulas are available for use in accordance with federal statutes and regulations of the Internal Revenue Service.1.20. coatings.. 4. any preparation compounded using denatured alcohol shall be identical to that prepared by the monograph process. although not from the ingredients or proportions thereof. Food and Drug Administration (FDA). The reference table is . details of the procedures. Information about an article’s “description and solubility” also is provided in the reference table Description and Relative Solubility of USP and NF Articles. General chapters may contain the following: • Descriptions of tests and procedures for application through individual monographs. General Chapters Each general chapter is assigned a number that appears in angle brackets adjacent to the chapter name (e. and safety of the preparation are not impaired. where appropriate. 5. in either case the denaturant shall be identified on the label of the topical preparation.10. 5.20. at times. having absolute (100 percent) purity. or (3) they interfere with the assays and tests prescribed for determining compliance with the compendial standards.2. as described in these compendia. and Ingredients in Official Products Suitable substances and excipients such as antimicrobial agents. Acceptance Criteria The acceptance criteria allow for analytical error. acceptance criteria may be presented after a colon. and. may occur provided that the finished preparation conforms to the relevant standards and to preparations produced by following the specified process. Excipients. as given in the complete chemical name of the article. or elegance. The air in a container of an official article may. or • General guidance to manufacturers of official substances or official products. Excipients. Description and Solubility Only where a quantitative solubility test is given in a monograph and is designated as such is it a test for purity. for unavoidable variations in manufacturing and compounding. A suitable formula of specially denatured alcohol may be substituted for Alcohol in the manufacture of official preparations intended for internal or topical use. • General information for the interpretation of the compendial requirements. When a general chapter is referenced in a monograph. provided such added substances or excipients are otherwise appropriate in all respects. Where a monograph for a compounded preparation calls for an ingredient in an amount expressed on the dried basis. Some chapters may serve as introductory overviews of a test or of analytical techniques.20.
. Any substance known to be toxic shall not be listed under Other Impurities. and • crude products of animal or plant origin.50. 5. Impurities and Foreign Substances Tests for the presence of impurities and foreign substances are provided to limit such substances to amounts that are unobjectionable under conditions in which the article is customarily employed (see also Impurities in Official Articles 〈1086〉). Unless a reference standard label bears a specific potency or content. The approximate solubility of a compendial substance is indicated by one of the following descriptive terms: Descriptive Term Very soluble Freely soluble Soluble Sparingly soluble Slightly soluble Very slightly soluble Practically insoluble. where the presence of the impurity is inconsistent with applicable good manufacturing practices or good pharmaceutical practice. units of potency are defined by the corresponding U.60. The Identity or Identification test for a particular article may consist of one or more procedures.40. Monographs refer to the units defined by USP Reference Standards as “USP Units. • biologics. The following categories of drug substances are excluded from Other Impurities requirements: • fermentation products and semi-synthetics derived therefrom. . under the heading Other Impurity(ies).000 USP 35 5. they must be of suitable quality. Identity A compendial test titled Identity or Identification is provided as an aid in verifying the identity of articles as they are purported to be.e. 5. using the general methods presented therein or other suitable methods.1% or greater. Safe Laboratory Practices In performing compendial procedures. • peptides.10. 5. Unless otherwise directed in the procedure in the individual monograph or in a general chapter. Standard established by FDA.000 From 1.0% pure in the official application.10. If any new USP or NF standard requires the use of a new USP Reference Standard that is not yet available. it is not intended to serve as a standard or test for purity.10. and dispense drugs and/or related articles. where both are known. and the solvents limited according to the principles defined and the requirements specified in Residual Solvents 〈467〉. USP Reference Standards USP Reference Standards are authentic specimens that have been approved as suitable for use as comparison standards in USP or NF tests and assays. Failure of an article to meet all the requirements of a prescribed Identity or Identification test (i. (See USP Reference Standards 〈11〉.000 Greater than or equal to 10.20. but instead are intended to serve as the official test in the event of a question or dispute regarding the preparation’s conformance to official standards. 5. • radiopharmaceuticals. • biotechnology-derived products. designated reference standard. assume the reference standard is 100. it may be necessary to express quantities of activity in biological units of potency. The presence of any unlabeled other impurity in an official substance is a variance from the standard if the content is 0. shall be stated in the labeling (certificate of analysis) of the official substance. safe laboratory practices shall be followed. with appropriate allowances made for differences in sample preparation. Units of Potency (Biological) For substances that cannot be completely characterized by chemical and physical means. prepare. other than a test for residual solvents. Before undertaking any procedure described in the compendia. Performance Tests Where content uniformity determinations have been made using the same analytical methodology specified in the Assay. failure to meet the requirements of all of the specified procedures that are components of that test) indicates that the article is mislabeled and/or adulterated. each defined by an authoritative. e. and that monograph procedure does not detect an impurity present in the substance. 5.80. a substance meeting all of the compendial monograph requirements for that article shall be used. whether or not International Units or USP Units have been defined (see Biologics 〈1041〉). 5. Assay Assay tests for compounded preparations are not intended for evaluating a compounded preparation before dispensing. Residual Solvents in USP and NF Articles All USP and NF articles are subject to relevant control of residual solvents. • herbals. Other Impurities in USP and NF Articles If a USP or NF monograph includes an assay or organic impurity test based on chromatography.70. the average of all of the individual content uniformity determinations may be used as the Assay value. all requirements of all specified procedures in the test must be met to satisfy the requirements of the test. that portion of the standard containing the requirement shall not be official until the specified USP reference material is available. The sum of all Other Impurities combined with the monograph-detected impurities may not exceed 2. and work practices consistent with the chemicals and procedures used. Although the information provided in monographs and the information in the reference table may indirectly assist in the preliminary evaluation of an article. 5. In addition.60. If solvents are used during production. When a compendial test for Identity or Identification is undertaken.. the amount and identity of the impurity. protective equipment.) Where a procedure calls for the use of a compendial article rather than for a USP Reference Standard as a material standard of reference.000 to 10.60.S. or Insoluble Parts of Solvent Required for 1 Part of Solute Less than 1 From 1 to 10 From 10 to 30 From 30 to 100 From 100 to 1. those taken from labeled containers. These compendia are not designed to describe such hazards or protective measures. including precautionary measures.50. TESTING PRACTICES AND PROCEDURES 6.6 General Notices intended primarily for those who use. 6.0% (see Ordinary Impurities 〈466〉). Units of biological potency defined by the World Health Organization (WHO) for International Biological Standards and International Biological Reference Preparations are termed International Units (IU). and to establish whether it is the article named in USP–NF.g.” For biological products. even when no test is specified in the individual monograph. USP Reference Standards are to be used in accordance with the instructions on the label of the Reference Standard. Nonmonograph tests and acceptance criteria suitable for detecting and controlling impurities that may result from a change in the processing methods or that may be introduced from external sources should be employed in addition to the tests provided in the individual monograph. the analyst should be aware of the hazards associated with the chemicals and the techniques and means of protecting against them. unless otherwise stated in the monograph. the toxicity and residual level of each solvent shall be taken into consideration.
any reference to USP or NF in their labeling shall include also the term “reagent” . When a difference appears. only the result obtained by the method and/or procedure given in the USP is conclusive. The portion of mixed Capsules contents taken shall be representative of the contents of the Capsules and shall. until two consecutive weighings. be weighed accurately. Unless otherwise indicated.1. Anhydrous. An expression such as “(20:5:2)” means that the respective numbers of parts. the second of which is taken after an additional period appropriate to the nature and quantity of the residue.20.20. or in other special circumstances. 6. provided that allowance is made for the difference in concentration and that the change does not increase the error of measurement.50.60. 6. Alternative and Harmonized Methods and Procedures Alternative methods and/or procedures may be used if they provide advantages in terms of accuracy. a solution of other normality or molarity may be used. compendial specifications for reagents of acceptable quality are provided (see the Reagents. and weighed accurately. Indicator Solutions Where a procedure specifies the use of an indicator TS. appropriate concentrations of that acid or base may be used.USP 35 6. including the indicators and solutions employed as reagents. and Solutions section of the USP–NF.50. 6. sensitivity.20. if a substance or preparation is found to comply with a requirement using an interchangeable method or procedure from one of these pharmacopeias. of the solution shall be added unless otherwise directed. Due to the possibility of filter effects. The portion of the powdered Tablets taken shall be representative of the whole Tablets and shall. An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with.40. is given in the monograph. solution concentrations may differ from the indicated value by more than ten percent (10%). a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. all solutions shall be prepared with Purified Water.50. Automated Procedures Automated and manual procedures employing the same basic chemistry are considered equivalent. Test Solutions Information on Test Solutions (TS) is provided in the Test Solutions portion of the Reagents. or Loss on Ignition. or adaptability to automation or computerized data reduction. a vacuum desiccator. mixed. Adjustments to Solutions When a specified concentration is called for in a procedure. unless otherwise indicated.40.10. in part. The term “previously dried” without qualification signifies that the substance shall be dried as directed under Loss on Drying 〈731〉 or Water Determination 〈921〉 (gravimetric determination). in no way implies that they have therapeutic utility. the second of which is taken after an additional drying period appropriate to the nature and quantity of the residue. in turn. Indicators. Reagents The proper conduct of the compendial procedures and the reliability of the results depend. Filtration Where a procedure gives direction to “filter” without further qualification. Test procedures may be performed on the undried or unignited substance and the results calculated on the dried. the contents of not fewer than a given number of the Capsules. a sufficient number of units to ensure a suitable analytical result shall be taken.70. Alternative procedures should be submitted to USP for evaluation as a potential replacement or addition to the standard (see section 4. or ignited basis.20. or Solvent-Free Basis All calculations in the compendia assume an “as-is” basis unless otherwise specified. 6. Use of an alternative Test Solution or a change in the Test Solution used may require validation.20. Capsules Where the procedure of a Capsule monograph gives direction to remove. as completely as possible. 6. Unless otherwise specified. selectivity. 6. Certain general chapters contain a statement that the text in question is harmonized with the corresponding text of the European Pharmacopoeia and/or the Japanese Pharmacopoeia and that these texts are interchangeable. furthermore. previous drying of the substance is specified in the individual monograph and is obligatory.40. approximately 0. The term “solvent-free” signifies that the calculation shall be corrected for the presence of known solvents as determined using the methods described in Residual Solvents 〈467〉 unless a test for limit of organic solvents is provided in the monograph. analyte concentrations shall be prepared to within ten percent (10%) of the indicated value. or Water.20.2. do not differ by more than 0. In the special case in which a procedure is adapted to the working range of an instrument. Where the presence of moisture or other volatile material may interfere with the procedure. Dried. respectively.60.50. Tablets Where the procedure of a Tablet monograph directs to weigh and finely powder not fewer than a given number of Tablets. 6. 6. precision. anhydrous. Ignite To Constant Weight “Ignite to constant weight” means that ignition shall be continued at 800 ± 25°. or in the event of dispute. Any changes shall fall within the validated range of the instrument.10.3. upon the quality of the reagents used in the performance of the procedures. or other suitable vacuum drying apparatus shall be used. Reagents not covered by any of these specifications should be of a grade suitable to the proper performance of the method of assay or test involved.10.20. Where drying in vacuum over a desiccant is directed. Solutions for quantitative measures shall General Notices 7 be prepared using accurately weighed or accurately measured analytes (see section 8. 6.30. Preparation of Solutions 6. provided a test for Loss on Drying. When adjustment of pH is indicated with either an acid or base and the concentration is not indicated. Monographs). a counted number of Capsules shall be carefully opened and the contents quantitatively removed.50 mg per g of substance taken. Solutions Unless otherwise specified. Indicators. Where such ACS reagent specifications are not available or where the required purity differs. it should comply with the requirements of the USP. Only those results obtained by the methods and procedures given in the compendium are conclusive. Therefore. or 3 drops. do not differ by more than 0.2 mL. reagents conforming to the specifications set forth in the current edition of Reagent Chemicals published by the American Chemical Society (ACS) shall be used.10. with appropriate changes in associated calculations. unless otherwise indicated.60. Listing of these reagents. and Solutions section of the USP–NF). Such alternative procedures and methods shall be validated as described in the general chapter Validation of Compendial Procedures 〈1225〉 and must be shown to give equivalent or better results. 6.50. Dried To Constant Weight “Dried to constant weight” means that drying shall be continued until two consecutive weighings. 6.50. the liquid shall be passed through suitable filter paper or equivalent device until the filtrate is clear. 6.20. combined. Ignited. a vacuum drying pistol. 6. be weighed accurately. a counted number of Tablets shall be weighed and reduced to a powder. by volume. in turn. About).50 mg per g of substance taken. the initial volumes of a filtrate may be discarded. of the designated liquids shall be mixed. Units Necessary to Complete a Test Unless otherwise specified. or 1 part by weight of a solid shall be dissolved in.
and Solutions section of USP–NF. Where acceptance criteria are expressed numerically herein through specification of an upper and/or lower limit. this identification is furnished solely for informational purposes as a matter of convenience.03% 0. If the measurement is stated to be “accurately measured” or “accurately weighed. TEST RESULTS 7.10. 8. slope for linearity) may be rounded for reporting purposes.80. a suitable volumetric flask may be substituted.20. 6.5 ppm 4 ppm 3.80. a suitable buret may be substituted.0% Assay limit ≤101.20. Nominal Concentrations in Equations Where a “nominal concentration” is specified.10. is mentioned (ordinarily in a footnote). or sorting devices are specified. Abbreviations • RS refers to a USP Reference Standard. either containers specially treated to protect contents from light or clear containers that have been rendered opaque by application of a suitable coating or wrapping may be used. Acceptance criteria are considered significant to the last digit shown. weighing.45% 101.5 ppm 3 ppm Conforms Yes No Yes No Yes Yes No Yes No No Yes Yes or “reagent grade. Instrumental Apparatus An instrument may be substituted for the specified instrument if the substitute uses the same fundamental principles of operation and is of equivalent or greater sensitivity and accuracy. Light Protection Where low-actinic or light-resistant containers are specified. The reportable value.20.027% 0. If this digit is equal to or greater than 5. water correction is typically stated in the Definition and on the label of the USP Reference Standard. Acceptance criteria are fixed numbers and are not rounded.9% 97. Other dimensions or types may be used if they are suitable for the intended use. Where a particular brand or source of a material. Equipment Unless otherwise specified. Pipet Where a pipet is specified. Indicators. Steam Bath Where use of a steam bath is directed. permitted values include the specified values themselves. 6.96% 98. or both is made prior to using the concentration in the equation provided in the monograph.. as documented.10. it is eliminated and the preceding digit is increased by 1.10. 6.46% 101.95% 98.4. Apparatus for Measurement Where volumetric flasks or other exact measuring.80. Corrections to calculations based on the blank determination are to be made for all titrimetric assays where appropriate (see Titrimetry 〈541〉).80. 7.5% 0. 6. potency.5. About “About” indicates a quantity within 10%.3.10.8 General Notices USP 35 Compendial Requirement Assay limit ≥98. is compared with the acceptance criteria. Equivalence Statements in Titrimetric Procedures The directions for titrimetric procedures conclude with a statement of the weight of the analyte that is equivalent to each mL of the standardized titrant.0% 101.5% 101.2. 6. endorsement. In assay procedures.0% 97. it is eliminated and the preceding digit is unchanged. or the name and address of a manufacturer or distributor.10. or certification.02% Limit test ≤3 ppm Illustration of Rounding Numerical Values for Comparison with Requirements Unrounded Value Rounded Result 97. 7.80.10. without implication of approval.g.80. this or other equipment of at least equivalent accuracy shall be employed. For other procedures.10. calculate the concentration based on the label claim. If this digit is smaller than 5.1. a specification for a definite size or type of container or apparatus in a procedure is given solely as a recommendation. 7. Chromatographic Tubes and Columns The term “diameter” refers to internal diameter (ID). but no values outside the limit(s). 6. Interpretation of Requirements Analytical results observed in the laboratory (or calculated from experimental measurements) are compared with stated acceptance criteria to determine whether the article conforms to compendial requirements. correction for assayed content. Tubing The term “diameter” refers to outside diameter (OD). 6. TERMS AND DEFINITIONS 8.4 ppm 3 ppm 2.92% 97. consider only one digit in the decimal place to the right of the last place in the limit expression.2. • VS refers to a Volumetric Solution that is standardized in accordance with directions given in the individual monograph or in the Reagents.20.55% 101. Intermediate calculations (e. use actively flowing steam or another regulated heat source controlled at an equivalent temperature. which often is a summary value for several individual determinations. instrument. 7.1. the number of significant figures in the concentration of the titrant should be understood to correspond to the number of significant figures in the weight of the analyte.20.015% 0.20.02% 0.” follow the statements in the gen- .80. In such an equivalence statement. The reportable value is the end result of a completed measurement procedure. • TS refers to a Test Solution. or piece of equipment. Numbers should not be rounded until the final calculations for the reportable value have been completed.025% 0. • CS refers to a Colorimetric Solution.” USP may supply reagents if they otherwise may not be generally commercially available.80.80.6% 101. but the original (not rounded) value should be used for any additional required calculations.03% 3. Rounding Rules The observed or calculated values shall be rounded off to the number of decimal places that is in agreement with the limit expression. 8. When rounding is required. Water Bath A water bath requires vigorously boiling water unless otherwise specified. These characteristics shall be qualified as appropriate. 6. 6. Where a “to contain” pipet is specified.20.5% Limit test ≤0.
Desiccator The instruction “in a desiccator” indicates use of a tightly closed container of suitable size and design that maintains an atmosphere of low moisture content by means of a suitable desiccant such as anhydrous calcium chloride. Normality is designated by the symbol N preceded by a number that represents the number of equivalents of the designated solute contained in an amount of the designated solvent that is sufficient to prepare 1 liter of solution. Temperatures Temperatures are expressed in centigrade (Celsius) degrees. magnesium perchlorate. the USP article Purified Water shall be used unless otherwise specified. any temperature not higher than 45°(113° F) is indicated. Symbols commonly employed for SI metric units and other units are as follows: . 8. the USP monograph article Alcohol shall be used. water meets the requirements of the appropriate water monograph in USP or NF. or assay calls for alcohol.” “NMT” means “not more than. or silica gel. as described in section 7.20. the determination shall be conducted using the same quantities of the same reagents treated in the same manner as the solution or mixture containing the portion of the substance under assay or test. Microbial Strain A microbial strain cited and identified by its ATCC catalog number shall be used directly or. if subcultured. 8. 8. Time Unless otherwise specified. Atomic Weights Atomic weights used in computing molecular weights and the factors in the assays and elsewhere are those established by the IUPAC Commission on Atomic Weights and Isotopic Abundances. 8. Rounding Rules. shall be used not more than five passages removed from the original strain. such as those under the heading Alcohol Content. 8. 8. Definitions of other types of water are provided in Water for Pharmaceutical Purposes 〈1231〉. 8. and all measurements are made at 25° unless otherwise indicated. 8. weights and measures are expressed in the International System of Units (SI) as established and revised by the Conf´ rence g´ n´ rale des poids et mesures. Where a formula.210. phosphorus pentoxide.220. apply to any time specified.190. Definitions for High-Purity Water and Carbon Dioxide-Free Water are provided in Containers—Glass 〈660〉.230. or 1 mL of a liquid.160.50 mg. Logarithms Logarithms are to the base 10. 8. or anhydrous alcohol. Concomitantly “Concomitantly” denotes that the determinations or measurements are to be performed in immediate succession. Reaction Time Reaction time is 5 minutes unless otherwise specified.10. Blank Determinations Where it is directed that “any necessary correction” be made by a blank determination. Negligible “Negligible” indicates a quantity not exceeding 0.60.200. 8. • For solutions or suspensions of solids in liquids.110. Where a procedure calls for dehydrated alcohol.130.220. the term “weight” is considered to be synonymous with “mass.” Molality is designated by the symbol m preceded by a number that represents the number of moles of the designated solute contained in 1 kilogram of the designated solvent.67 kPas) or at the pressure designated in the individual monograph. Water in a Compendial Procedure When water is called for in a compendial procedure. 8. test. Where reference is made to “C2H5OH. unless otherwise indicated.USP 35 eral chapters Volumetric Apparatus 〈31〉 and Weights and Balances 〈41〉.150. 8.180.” “a faint characteristic odor. ethyl alcohol. See also section 8. Vacuum Desiccator. or ethanol.56°. Molarity is designated by the symbol M preceded by a number that represents the number of moles of the designated solute contained in an amount of the designated solvent that is sufficient to prepare 1 liter of solution. Specific Gravity Specific gravity is the weight of a substance in air at 25° divided by the weight of an equal volume of water at the same temperature. 8.50. • For solutions of gases in liquids.240. Pressure Pressure is determined by use of a suitable manometer or barometer calibrated in terms of the pressure exerted by a column of mercury of the stated height. Vacuum “Vacuum” denotes exposure to a pressure of less than 20 mm of mercury (2. General Notices 9 • Percent Weight in Volume (w/v) is defined as number of g of a solute in 100 mL of solution. Percent “Percent” used without qualification means: • For mixtures of solids and semisolids.” 8.20. • Percent Volume in Volume (v/v) is defined as the number of mL of a solute in 100 mL of solution. alcohol absolute.120. rounding rules.80. • For solutions of liquids in liquids. but with the substance itself omitted. 8.70. the USP monograph article Dehydrated Alcohol shall be used. 8. Weights and Measures In general. respectively. Water in the Manufacture of Official Substances When used in the manufacture of official substances. 8.140. in sufficient solvent to make 100 mL of the solution.30.100. 8. 8.” absolute (100 percent) ethanol is intended. Where moderate heat is specified.” and variations thereof indicate evaluation of a suitable quantity of freshly opened material after exposure to the air for 15 minutes.170. Vacuum Desiccator “Vacuum desiccator” indicates a desiccator that maintains a low-moisture atmosphere at a reduced pressure of not more than 20 mm of mercury (2. NLT/NMT “NLT” means “not less than.” “practically odorless. 8. Alcohol Content Percentages of alcohol.40. a 1 percent solution is prepared by dissolving 1 g of a solid or semisolid. 8. Environmental Protection Agency (potable water). percent volume in volume. refer to percentage by volume of C2H5OH at 15.230. percent weight in weight. water may meet the requirements for drinking water as set forth in the regulations of the U. Odor “Odorless. percent weight in volume. For come e e pendial purposes. 8.S. Transfer “Transfer” indicates a quantitative manipulation. An odor designation is descriptive only and should not be regarded as a standard of purity for a particular lot of an article. 8. Water as an Ingredient in an Official Product As an ingredient in an official product.30. 8. For example.230.230. percent weight in volume.90.67 kPas). Percentage Concentrations Percentage concentrations are expressed as follows: • Percent Weight in Weight (w/w) is defined as the number of g of a solute in 100 g of solution. Water 8.
unless otherwise indicated in the individual monograph.10 General Notices Bq = becquerel kBq = kilobecquerel MBq = megabecquerel GBq = gigabecquerel Ci = curie mCi = millicurie µCi = microcurie nCi = nanocurie dL = deciliter L = liter mL = milliliterc µL = microliter Eq = gram-equivalent weight mEq = milliequivalent mol = gram-molecular weight (mole) Da = dalton (relative molecular mass) mmol = millimole Osmol = osmole mOsmol = milliosmole Hz = hertz kHz = kilohertz MHz = megahertz V = volts MeV = million electron volts keV = kilo-electron volt mV = millivolt psi = pounds per square inch Pa = pascal kPa = kilopascal g = gravity (in centrifugation) USP 35 tainer is that which is in direct contact with the article at all times. Hermetic Container A hermetic container is impervious to air or any other gas under the ordinary or customary conditions of handling.20. except where extemporaneously compounded for immediate dispensing on prescription. 10. slight changes in volume owing to variations in room temperatures may be disregarded. cyclopropane. and. shipment. Articles intended for sale without prescription are also required to comply with the tamper-evident packaging and labeling requirements of the FDA where applicable. from loss of the article. Preferably. Such articles shall be protected from moisture. mcg = microgramb ng = nanogram pg = picogram fg = femtogram a Previously the symbol mµ (for millimicron) was used. Where it is directed to “protect from light” in an individual monograph. the container should be clean.001mm) nm = nanometera kg = kilogram g = gram mg = milligram µg. solids. storage. shipment. AND LABELING 10. and. If an amount is prescribed by any other system of measurement. Storage Under Nonspecific Conditions If no specific directions or limitations are provided in the Packaging and Storage section of an individual USP monograph or in the labeling of an article recognized in USP. Where an article is required to be packaged in a lightresistant container. Tamper-Evident Packaging The container or individual carton of a sterile article intended for ophthalmic or otic use. excessive heat. PRESERVATION. protection from light. but micrograms may be represented as “mcg” for labeling and prescribing purposes.20.20 Changes in Volume In the dispensing of prescription medications. the PinIndex Safety System of matched fittings is recommended for cylinders of Size E or smaller. in which case the label of the container bears a statement that the opaque covering is needed until the contents are to be used or administered.” symbolized by γ. shipment. Drug substances are exempt from the requirements in this paragraph. and from efflorescence. section 5. 10.50. or evaporation under the ordinary or customary conditions of handling. and excessive heat. storage. STORAGE. or purity of the article beyond the official requirements.10 above). from light during shipping and distribution. The compendial requirements for the use of specified containers apply also to articles as packaged by the pharmacist or other dispenser. Special precautions and cleaning procedures may be necessary to ensure that each container is clean and that extraneous matter is not introduced into or onto the article. protection from moisture. the conditions of storage shall include storage at controlled room temperature. [NOTE—Where packaging and storage in a tight container or a well-closed container is specified in the individual monograph.20. b The symbol µg is used in the USP and NF to represent micrograms. and is capable of tight reclosure. helium. Apothecary unit designations on labels and labeling shall not be used. the immediate container and/or the outer container or protective packaging used by a manufacturer or distributor for all dosage forms that are not specifically exempt is designed so as to show evidence of any tampering with the contents. As a safety measure. 10. Containers The container is that which holds the article and is or may be in direct contact with the article. Alternatively. where no specific storage directions or limitations are provided in an individual NF monograph or stated in the labeling of an article recognized in NF. preservation in a light-resistant container is intended. PRESCRIBING AND DISPENSING 9. where necessary. frequently is used to represent micrograms in biochemical literature. Regardless of quantity. A gas cylinder is a metallic container designed to hold a gas under pressure. The term “gamma. nitrous oxide.20. and.10 Use of Metric Units Prescriptions for compendial articles shall be written to state the quantity and/or strength desired in metric units unless otherwise indicated in the individual monograph (see also Units of Potency. The container does not interact physically or chemically with the article placed in it so as to alter the strength.20. where necessary. and distribution. Light-Resistant Container A light-resistant container (see Light Transmission Test under Containers—Performance Testing 〈671〉) protects the contents from the effects of light by virtue of the specific properties of the material of which it is composed. only an amount that is the metric equivalent of the prescribed amount shall be dispensed. from light. Tight Container A tight container protects the contents from contamination by extraneous liquids. 10. The immediate con- . a clear and colorless or a translucent container may be made light-resistant by means of an opaque covering. a single-use.20.40. PACKAGING. for carbon dioxide. freezing. 9. 9. the container used for an article when dispensed on prescription meets the requirements under Containers—Performance Testing 〈671〉. quality. the conditions of storage and distribution shall include protection from moisture.50. Well-Closed Container A well-closed container protects the contents from extraneous solids and from loss of the article under the ordinary or customary conditions of handling.10. freezing. deliquescence. and oxygen. Gy = gray mGy = milligray m = meter dm = decimeter cm = centimeter mm = millimeter µm = micrometer (0.] 10. Where a tight container is specified. unitdose container or mnemonic pack for dispensing may not be removed from the outer opaque covering before dispensing. and distribution.20. and distribution. or vapors. 10. The closure is a part of the container. storage. where necessary. and if the container is made light-resistant by means of an opaque covering. c One milliliter (mL) is used herein as the equivalent of one cubic centimeter (cc).10. shall be so sealed that the contents cannot be used without obvious destruction of the seal. Before being filled.30. it may be replaced by a hermetic container for a single dose of an article. 10. including any coating applied to it.
Such directions apply except where the label on an article states a different storage temperature on the basis of stability studies of that particular formulation. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations.20.20.90. 10. unless otherwise specified in the individual monograph or on the label. certain dietary supplements. 10.60. 10.80.70. unless otherwise specified by the individual monograph.120. Controlled Room Temperature “Controlled room temperature” indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° (68° to 77°F).20). Unit-Dose Container A unit-dose container is a single-unit container for articles intended for administration by other than the parenteral route as a single dose. (See also Containers for Injections under Injections 〈1〉. the . Cold Any temperature not exceeding 8° (46°F) is “cold. Single-Unit Container A single-unit container is one that is designed to hold a quantity of drug product intended for administration as a single dose or a single finished device intended for use promptly after the container is opened. Each single-unit container shall be labeled to indicate the identity. cartridges.30. in addition to the risk of breakage of the container.30. Cool Any temperature between 8° and 15° (46° and 59°F) is“cool. quantity and/or strength.90. and warehouses. and many over-the-counter (OTC) drug preparations in order to protect the public from personal injury or illness from misuse of these preparations (16 CFR § 1700.5). fusion-sealed containers. 10. 10.30. (See also Containers for Injections under Injections 〈1〉). Room Temperature “Room temperature” indicates the temperature prevailing in a working area. freezing subjects an article to loss of strength or potency.20. (See also Pharmaceutical Stability 〈1150〉.14).20.) 10.30. hospitals. Transient spikes up to 25° (77° F) may be permitted if the manufacturer so instructs and provided that such spikes do not exceed 24 hours unless supported by stability data or the manufacturer instructs otherwise. Storage Temperature and Humidity Specific directions are stated in some monographs with respect to the temperatures and humidity at which official articles shall be stored and distributed (including the ship- General Notices 11 ment of articles to the consumer) when stability data indicate that storage and distribution at a lower or a higher temperature and a higher humidity produce undesirable results. or other wording based on the same mean kinetic temperature. Single-Dose Container A single-dose container is a single-unit container for articles intended for parenteral administration only. Preferably. 10. Provided the mean kinetic temperature remains in the allowed range. the immediate container and/or the outer container or protective packaging shall be so designed as to show evidence of any tampering with the contents. or purity of the remaining portion. and closure-sealed containers when so labeled. that allows for excursions in temperature between 0° and 15° (32° and 59° F) that may be experienced during storage. 10. quality. Protection From Freezing Where.USP 35 10. shipping.15 and 16 CFR § 1700. Warm Any temperature between 30° and 40° (86° and 104°F) is “warm.S. such labeled storage directions apply. 10. Manufacturers and packagers of bulk-packaged prescription drugs do not have to use special packaging if the drug will be repackaged by the pharmacist. The non–child-resistant package requires special labeling (16 CFR § 1700. PPPA-regulated prescription drugs may be dispensed in non–child-resistant packaging upon the request of the purchaser or when directed in a legitimate prescription (15 U. direct from the container.110. (See also Pharmaceutical Stability 〈1150〉. nonclosable. 10. Articles may be labeled for storage at “controlled room temperature” or at “up to 25°”.60. Examples of single-dose containers include prefilled syringes. § 1473). Freezer “Freezer” indicates a place in which the temperature is maintained thermostatically between −25° and −10° (−13° and 14°F). Multiple-Dose Container A multiple-dose container is a multiple-unit container for articles intended for parenteral administration only.C. and unit-dose types. special packages are also supplied.100. 10. A unit-of-use container is labeled as such.10.” 10.40. and that allows for excursions between 15° and 30° (59° and 86°F) that are experienced in pharmacies. www. alternatively.30. name of the manufacturer.20. Controlled Cold Temperature “Controlled cold temperature” is defined as temperature maintained thermostatically between 2° and 8° (36° and 46° F). Where no specific storage directions or limitations are provided in the individual monograph.30. The PPPA regulations for special packaging apply to all packaging types including reclosable. Unit-of-Use Container A unit-of-use container is one that contains a specific quantity of a drug product and that is intended to be dispensed as such without further modification except for the addition of appropriate labeling. lot number. Multiple-Unit Container A multiple-unit container is a container that permits withdrawal of successive portions of the contents without changing the strength. or to destructive alteration of its characteristics.gov/businfo/pppa. but the label of an article states a storage temperature that is based on stability studies of that particular formulation.cpsc.) An article for which storage at controlled room temperature is directed may.20. The immediate packaging of substances regulated under the PPPA shall comply with the special packaging standards (16 CFR § 1700.50.20. 10. Special packaging is not required for drugs dispensed within a hospital setting for inpatient administration. alternatively. Requirements under the Poison Prevention Packaging Act (PPPA) This act (see the website.30. transient spikes up to 40° are permitted as long as they do not exceed 24 hours. 10. Various types of child-resistant packages are covered in ASTM International Standard D-3475.30.) The conditions are defined by the following terms.20. A singledose container is labeled as such. oral controlled drugs.30.html) requires special packaging of most human oral prescription drugs. Excessive Heat “Excessive heat” means any temperature above 40° (104°F). certain non-oral prescription drugs. 10. and distribution such that the allowable calculated mean kinetic temperature is not more than 8° (46° F).70. Standard Classification of Child-Resistant Packaging.” A “refrigerator” is a cold place in which the temperature is maintained thermostatically between 2° and 8° (36° and 46°F). Spikes above 40° may be permitted if the manufacturer so instructs. Manufacturers or packagers of PPPA-regulated OTC preparations are allowed to package one size in non–child-resistant packaging as long as popular-size.30. Examples are included as an aid in the understanding and comprehension of each type of classification. be stored and distributed in a cool place.” An article for which storage in a cool place is directed may. that results in a mean kinetic temperature calculated to be not more than 25°. be stored and distributed in a refrigerator.30. and expiration date of the article. 10.80.
control number. Use of Leading and Terminal Zeros To help minimize the possibility of errors in the dispensing and administration of drugs.20.40. Labeling of Salts of Drugs It is an established principle that official articles shall have only one official title.100. [NOTE—For additional information and guidance. or to express the percentage of each such ingredient (see 8. 10. Both the active moiety and drug substance names and their equivalent amounts are then provided in the labeling. Where an official article is required to bear an expiration date.. or other unit dosage form shall be labeled to express the quantity of each active ingredient or recognized nutrient contained in each such unit.30. 10.0 mg]). in the case of unit-dose oral solutions or suspensions.g. USP 35 and because chemical symbols for the most common inorganic salts of drugs are well known to practitioners as synonymous with the written forms. Articles in these compendia are subject to compliance with such labeling requirements as may be promulgated by governmental bodies in addition to the compendial requirements set forth for the articles. Official drug products not in unit dosage form shall be labeled to express the quantity of each active ingredient in each milliliter or in each gram. be labeled in terms of each 5-mL portion of the liquid or resulting liquid.140.2 mg [not . All articles shall display the expiration date so that it can be read by an ordinary individual under customary conditions of purchase and use. expiration date. such declarations of strength or quantity shall be stated only in metric units. Labeling Botanical-Containing Products The label of an herb or other botanical intended for use as a dietary supplement bears the statement. except that oral liquids or solids intended to be constituted to yield oral liquids may. A shipping container containing a single article..g. or batch number.90. 10. Units of Potency (Biological). whichever form is used in the title. Determination is based on not less than 12 equally spaced measurements that encompass either a season.10.g.40. printed. Excipients.g. 10. a year. Phenobarbital Na is acceptable. The amounts of vitamins A. HBr for hydrobromide. Amount of Ingredient Per Dosage Unit The strength of a drug product is expressed on the container label in terms of micrograms or milligrams or grams or percentage of the therapeutically active moiety or drug substance.30. the label shall express the quantity of each active ingredient or recognized nutrient delivered under the conditions prescribed in Deliverable Volume 〈698〉. unless such container is also essentially the immediate container or the outside of the consumer package. 10.” “Exp.40. June 08. 10. sodium chloride or potassium chloride) shall be stated on the label in milliequivalents (mEq).40. 10. Official articles in capsule.40. For purposes of saving space on labels.50.” or “Expires 6/08”). seek the advice of a health professional before using this product. whether supplied as liquid preparations or as liquid preparations that are constituted from solids upon addition of a designated volume of a specific diluent.. and Ingredients and see Labeling under Injections 〈1〉). a .70. and which is stable for not less than 3 years when stored under the prescribed conditions. and conditions for storage and distribution. the quantity of active ingredient when expressed in whole numbers shall be shown without a decimal point that is followed by a terminal zero (e.12 General Notices container label bears an appropriate instruction to protect the article from freezing. Storage in a container validated to protect the article from moisture vapor. Expiration Date and Beyond-Use Date The label of an official drug product or nutritional or dietary supplement product shall bear an expiration date. is considered storage in a dry place. 10. and E may be stated also in USP Units. with the following exception: the label need not show an expiration date in the case of a drug product or nutritional supplement packaged in a container that is intended for sale without prescription and the labeling of which states no dosage limitations. and easily understood (e.g. and. except that. Labeling Electrolytes The concentration and dosage of electrolytes for replacement therapy (e. also their amounts or proportions. The symbols Na and K are intended for use in abbreviating names of the salts of organic acids. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. any package or wrapper in which it is enclosed. the storage period of the article. Labeling Parenteral And Topical Preparations The label of a preparation intended for parenteral or topical use states the names of all added substances (see 5.. Special Capsules and Tablets The label of any form of Capsule or Tablet intended for administration other than by swallowing intact bears a prominent indication of the manner in which it shall be used. Unless otherwise indicated in a monograph or chapter.” 10.2 mg]).. tablet. the label may indicate only their presence and the reason for their addition. the label shall bear an expiration date assigned for the particular formulation and package of the article. in the case of parenteral preparations. D. The label of the product shall indicate also the quantity of ingredient(s) in terms of weight or percentage concentration. the following alternatives are permitted in labeling official articles that are salts: HCl for hydrochloride.40.50. and K for potassium. but Na Salicylate is not to be written). Labeling Alcohol The content of alcohol in a liquid preparation shall be stated on the label as a percentage (v/v) of C2H5OH. 10. where recorded data demonstrate. except that for substances added for adjustment of pH or to achieve isotonicity. unless otherwise indicated in an individual monograph. but these symbols are not used where the word Sodium or Potassium appears at the beginning of an official title (e.20.80. express as 0. “EXP 6/08. except any outer shipping container. In the absence of a specific requirement in the individual monograph for a drug product or nutritional supplement. Labeling The term “labeling” designates all labels and other written. or from. Percentage Concentrations). Na for sodium.] The monographs for some preparations state how the expiration date that shall appear on the label shall be determined.. “If you are pregnant or nursing a baby.. See also 5. or in.10. Dry Place The term “dry place” denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures.40. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity. lot number.60. or graphic matter upon an immediate container of an article or upon. The expiration date shall be prominently displayed in high contrast to the background or sharply embossed. The quantity of active ingredient when expressed as a decimal number smaller than 1 shall be shown with a zero preceding the decimal point (e. is labeled with a minimum of product identification (except for controlled articles). or.40.100. 10.40.40. Labeling Vitamin-Containing Products The vitamin content of an official drug product shall be stated on the label in metric units per dosage unit. Quantities of vitamin A declared in metric units refer to the equivalent amounts of retinol (vitamin A alcohol). 10. including storage in bulk. such article shall be dispensed solely in. The label of a nutritional supplement shall bear an identifying lot number.40. refer to the Consumer Healthcare Products Association’s Voluntary Codes and Guidelines of the Self-Medication Industry.40. Added Substances. express as 4 mg [not 4. alternatively. The term “label” designates that part of the labeling upon the immediate container..
The monograph for an official compounded preparation typically includes a beyond-use requirement that states the time period following the date of compounding during which the preparation. the choice would appear to be tight. or (b) 1 year from the date the drug is dispensed. For excipients. where needed. and the date on which the article is dispensed shall be within the labeled expiry period. in addition to any other relevant factors. in the absence of data indicating a need for a more protective class of container. For nonsterile solid and liquid dosage forms that are packaged in single-unit and unit-dose containers. . light-resistant containers and stored at controlled room temperature unless otherwise indicated (see Stability Criteria and Beyond-Use Dating under Stability of Compounded Preparations in the general test chapter Pharmaceutical Compounding—Nonsterile Preparations 〈795〉). The beyond-use date is the date after which an article shall not be used. the beyond-use date shall be 1 year from the date the drug is packaged into the single-unit or unit-dose container or the expiration date on the manufacturer’s container. For drug substances.). unless stability data or the manufacturer’s labeling indicates otherwise. Hermetic Container. hermetic. Tight Container. their beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products. Single-Dose Container. the choice is determined by the container in which it shall be dispensed (e.50. in determining an appropriate period of time during which a prescription drug may be retained by a patient after its dispensing. at a temperature such that the mean kinetic temperature is not greater than 25°. Well-Closed Container. properly stored. the expected storage conditions to which the article may be exposed. recommendations for maximum beyond-use dates have been devised for nonsterile compounded drug preparations that are packaged in tight.40.1. well-closed. with containers ranging from drums to tank cars. and Unit-of-Use Container. The plastic material used in packaging the dosage forms shall afford better protection than polyvinyl chloride. Single-Unit Container. or.USP 35 container labeled with an expiration date. Records shall be kept of the temperature of the facility where the dosage forms are stored. the characteristics of the patient’s container. a well-closed container is an appropriate default. Preservation. 10. the phrase “Preserve in well-closed containers” should be used as a default for excipients. Packaging. The dispenser shall place on the label of the prescription container a suitable beyond-use date to limit the patient’s use of the article based on any information supplied by the manufacturer and the General Notices. Because compounded preparations are intended for administration immediately or following short-term storage. Guidelines for Packaging and Storage Statements in USP–NF Monographs In order to provide users of the USP and NF with proper guidance on how to package and store official articles. For the packaging portion of the statement. provided it is kept under the prescribed storage conditions. it is a representation that the intended expiration date is the last day of the stated month. which does General Notices 13 not provide adequate protection against moisture permeation. Compounded Preparations The label on the container or package of an official compounded preparation shall bear a beyond-use date. if the article is repackaged for dispensing. Where an expiration date is stated only in terms of the month and the year. For all other dosage forms. such beyond-use date shall be not later than (a) the expiration date on the manufacturer’s container. The beyond-use date placed on the label shall not be later than the expiration date on the manufacturer’s container. and includes Light-Resistant Container. etc.g. For most preparations. the choice of containers is given in this section 10. the container in which it was packaged by the manufacturer and the expiration date thereon. well-closed. a light-resistant container. the nature of the drug. given their typical nature as large-volume commodity items. every monograph in the USP and NF shall have a packaging and storage specification.100. Unless otherwise specified in the individual monograph. The expiration date identifies the time during which the article may be expected to meet the requirements of the compendial monograph. the dispenser shall take into account. The expiration date limits the time during which the article may be dispensed or used. whichever is earlier. and Labeling. For articles requiring constitution before use. In the absence of stability information that is applicable to a specific drug and preparation. may be used. whichever is earlier. on taking into account the foregoing. Therefore. The dispenser shall maintain the facility where the dosage forms are packaged and stored. unit-of-use. The beyond-use date is the date after which a compounded preparation is not to be used. place on the label of a multiple-unit container a suitable beyond-use date to limit the patient’s use of the article. Unit-Dose Container. and the expected length of time of the course of therapy.. any unusual storage conditions to which the article may be exposed. tight. a suitable beyond-use date for the constituted product shall be identified in the labeling. 10. Storage. or in the absence of stability data to the contrary. The dispenser shall. and of the plastic materials used in packaging.
Documents Similar To Usp 35-Nf 30 General Notices
Determination of lignin
girmaye
Or Series Brochure
easygoing32
FPH-pressurefilter
IJMAI-01-201
Filtration of Pectin Extract From Grapefruit Peel and Viscosity of Pectins Solutions
Miguel Angel Varas Condori
Wc 500121604
kmshah88
F1091.1479757-1
Condensate Polishers Add Operating Reliability and Flexibility
Salvia Divinorum Extraction FAQ
pharmaceutical excipients(USP)
chaja1
cGMP regulations of Sterile Products
Sukesh Potla
Janairo_23_rx biuret
Lda Devi
Valid Sterisart-NF SLD5704-e
sizhusy
CCEA Chem Revision Book Answers
Ashik Aslam
api-77624700
Pharmacophore-2011-2-2-32
PENGARUH ABSORBSI KARBON AKTIF KAYU ASEM DAN PASIR KALI PUTIH TERHADAP EFISIENSI TRANSMISI CAHAYA PADA PROSES PENJERNIHAN AIR SELOKAN MATARAM
powerpoint slides - separation techniques
Leaching 7
QC Westgard SPC
erty543 er
Particle Lab New Manual New
Nfc 12 Hepas a4 Version_2