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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover
 

9. Simple test methodology

Basic tests for verifying the identity of pharmaceutical substances and their associated dosage forms have now been published (6, 7) or are in the course of development for the majority of the substances in the current WHO Model List of Essential Drugs (1). The Committee recommended that the reagents specified for use in such tests should be chosen with care with respect to both their availability and their toxicity. In response to earlier suggestions (4) that complementary tests should be developed to detect gross degradation, a thin-layer chromatographic (TLC) procedure was in the course of evaluation. The Committee agreed that, providing such a procedure was shown to be sufficiently reliable, it could be recommended for use as a basic test.

 

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