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
Close this folder2. The international pharmacopoeia and related activities
View the document2.1. Quality specifications for drug substances and dosage forms
View the document2.2. Dissolution test for solid oral dosage forms: paddle method
View the document2.3. Therapeutic equivalence of multisource products
View the document2.4. International nonproprietary names for pharmaceutical substances
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
 

2.1. Quality specifications for drug substances and dosage forms

The Committee was pleased to note that publication of Volume 4 of The international pharmacopoeia, containing additional monographs on pharmaceutical substances, excipients and dosage forms together with supporting test methods and general requirements, was expected in 1993.

The Committee considered, and recommended for inclusion in a future publication, monographs on ophthalmic drops and ointments and on suppositories, and test methods for the disintegration of suppositories and for the sterility of non-injectable preparations. It noted the progress made jointly with experts from the European Pharmacopoeia Commission on developing a test for visible particulate matter in injectable preparations.

The Committee confirmed that the requirements of The international pharmacopoeia should continue to be based on reliable methods widely available in small control laboratories. Such a policy is consistent with the unique role of The international pharmacopoeia. However, in some circumstances, the provision of more complex methods as alternatives might be considered.

It was suggested that it would be helpful for WHO to obtain information about users of The international pharmacopoeia in order to ascertain more precisely by whom and for what purposes it is currently used.

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