Identification The identification test(s) must be able to unambiguously distinguish the substance from any other substance, and may include ‘fingerprint’ tests such as TLC, HPLC or IR which must be compared to an authenticated reference material. More than one test may be appropriate. For pure substances, chromatographic retention time alone is generally considered inadequate as a method of identification. Add rows as necessary. List methods of identification. Refer to pharmacopoeial methods where possible (attach details of proprietary methods). Complies, for example: matches spectrum of authenticated reference material. Describe test(s) that determine the presence and quantity of a specific substance. In case of herbal materials, preparations, or other complex mixtures (for example: herbal extracts), appropriate marker compounds may be assayed. Add rows as necessary. State and if necessary describe methods of assay or provide brief details. Limits for assay(s) taking into account practical but reasonable biological, physical and chemical variation. Notes * The residue on ignition test and sulphated ash test are appropriate as characteristics when performed on inorganic material. For organic substances, the test should be included under “Other organic or inorganic impurities or toxins”. Table 2. Incidental constituents Where justified, certain tests for incidental constituents may be excluded based on the origin and processing of the substance, for example: a dried leaf, otherwise unprocessed, may be exempted from residual solvent testing. Other incidentals, such as scheduled contaminants (for example: bromides, ephedrine) or radioactivity should be included where appropriate. Test Method reference Acceptance criteria
Residual Solvents Specifically address solvents that are included in the BP Appendix VIII L. Address any additional solvents that may be used in the production, preparation, manufacturing or formulation. Add rows as necessary. List methods of assay, for example: BP 2011 (Appendix VIII L, Residual solvents; Ph Eur method 2.4.24). Complies, but where limits exceed recommendations of pharmacopoeia monograph, limits should be specified. Solvent specific limits of any solvents not specified in BP 2011 (Appendix VIII L) Incidental metals and non-metals Specifically address the metals in the current BP or other default standard (Ph Eur, USP) limit test for heavy metals. Include total heavy metals and/or any limits for specific metals or non-metals, for example: lead, cadmium, mercury, arsenic, cyanide Add rows as necessary. List methods of assay, for example: BP 2011 (Appendix VII); Ph Eur method 2.4.8 or in-house. Limits of total heavy metals Metal specific limits Pesticide residues and environmental contaminants: (including agricultural and veterinary substances) Specifically address the limits stipulated in the current BP (or Ph Eur, USP), and whether the product would comply with these limits. In addition, state any additional residue limits that may be relevant. Add rows as necessary. List methods of assay, for example: BP 2011(Appendix XI L, Pesticide residues; Ph Eur method 2.8.13). Complies organic or inorganic impurities or toxins Include other substances that may pose a safety risk, or may be of therapeutic significance. List methods of assay, refer to pharmacopoeial methods where possible, for example: BP, Ph Eur, USP. Limits of total impurities in substance Impurity specific limits