. /.WORLD TRADE
ORGANIZATIONG/TBT/N/ARG/120
15 July 2003
(03-3839)
Committee on Technical Barriers to Trade Original:  Spanish
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   ARGENTINA
If applicable, name of local government involved (Articles 3.2 and 7.2):
2. Agency responsible:  National Executive
Name and address (including telephone and fax numbers and E-mail and Web site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:   Idem  National
enquiry point.
3. Notified under Article 2.9.2 [  X ], 2.10.1 [    ], 5.6.2 [   ], 5.7.1 [    ], other:
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):
5. Title, number of pages and language(s) of the notified document:  Argentine
Pharmacopoeia, Volume I, 7th Edition  (184 pages, in Spanish).
6. Description of content:  Preface; Presentation;  Objectives;  History;  Legislation;
Technical Subcommittees, composition;  General Notices.
General Methods of Analysis:Thermal analysis;  Acid neutralizing capacity;  Total organic carbon;  Colourants for
pharmaceutical use;  Oxygen flask combustion;  Conductivity;  Preservatives;  Hygiene
control of products not subject to a sterility requirement;  Chromatography.
Determination of aflatoxins, water, alcohol, aluminium, zinc, relative density, optical
rotation, solidification temperature, viscosity, nitrogen, extractable container contents, net
container contents, refractive index, distillation interval, pH, melting point, residue on
ignition.Complete dissolution;  Fine particle size distribution;  Electrophoresis.
Disintegration test;  Dissolution test;  Tests for bacterial endotoxins, pyrogens, readily
carbonizable substances, abnormal toxicity, sterility, and biological reactivity;
Pharmaceutical-technical tests for aerosols and for suppositories;  General identification
tests.Primary packaging materials of plastic and glass.
Atomic absorption, atomic emission, fluorescence, infrared, ultraviolet and visible
spectrophotometry.
Fixed fats and oils;  Identification of organic nitrogenous bases and tetracyclines;  Common
and volatile organic impurities;  Release of active ingredients.Limits for arsenic, calcium, potassium and sodium, chloride and sulphate, dimethylaniline,
iron, heavy metals, lead, selenium.
Volumetric materials;  Methods in pharmacognosy;  Osmolarity;
Particulate matter in injectable preparations and Metal particles in ophthalmic ointments.
Loss by calcination and loss on drying.G/TBT/N/ARG/120
Page 2
6. Description of content:   (cont'd)
Weights and balances;  Polarography;  Salts of organic nitrogenous bases;  Thermometers;
Nitrite titration;  Uniformity of dosage units.
Assay of steroids, iodometric assay of beta-lactam antibiotics, microbiological and
volumetric assays.General texts: Good manufacturing and control practices; Stability testing;
Dosage forms; Tablet friability and hardness, Impurities in official products; Cleaning of
glass materials;  Radiopharmaceutical preparations;  Biotechnological products; Validation
of analytical methods.
Reagents and solutions:
Specifications for reagents, indicators, strips and indicator strips; Regulator, colorimetric,
reagent indicator and volumetric solutions.Tables
The standards and specifications in this publication are intended for consultation by Health
Authority staff, manufacturers, health professionals, researchers and teaching staff, all of
whom are involved in ensuring that medicines meet the quality requirements which
guarantee their safe use.These standards and specifications shall be mandatory for all pharmacies, chemist's shops,
drugstores and companies and establishments which manufacture, import, market and/or
distribute drugs and medicines or medical products the characteristics of which make them
subject to compliance with Argentine Pharmacopoeia specifications.
7. Objective and rationale, including the na ture of urgent problems where applicable: 
The main aim of the Argentine Pharmacopoeia is to help to promote public health
by establishing quality standards for products used in the manufacture of medicines.  Thereis therefore a need for the Pharmacopoeia, beginning with the Seventh Edition of Volume I,
to be reviewed and updated to bring it into lin e with advances in therapeutics, technological
development and the growth of the pharmaceutical industry.
8. Relevant documents:  Decree No. 202/2003
9. Proposed date of adoption:  17 June 2003 (Official Journal)
Proposed date of entry into force:  17 June 2003
10. Final date for comments:   -
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax
numbers and E-mail and Web site addresses, if available, of the other body:
Focal Point of the Argentine Republic
National Directorate of Domestic Trade (DNCI)
Avda. J. A. Roca 651, 4th floor, Sector 2 (C1067ABB) Buenos Aires
Fax:  (54 11) 4349-4072Tel.: (54 11) 4349-4076
E-mail: focalotc@mecon.gov.ar
Web site: http://www.puntofocal.gov.ar