WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] 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 issues
Close this folder3. International Chemical Reference Substances and Infrared Reference Spectra
View the document3.1 Establishment of International Chemical Reference Substances
View the document3.2 International Infrared Reference Spectra
View the document3.3 Use of International Chemical Reference Substances and Infrared Reference Spectra
View the document3.4 Guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
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 Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

3.3 Use of International Chemical Reference Substances and Infrared Reference Spectra

The results of a questionnaire on the use of International Chemical Reference Substances and Infrared Reference Spectra were reported to the Committee. The majority of the answers came from national quality control laboratories (40.4%), pharmaceutical manufacturers (22.6%) and teaching and research institutions (19.8%). It was noted that the substances are mainly used as primary standards to calibrate working standards, but also to some extent directly as working standards. This probably reflects a single or infrequent use where it is not sensible to prepare a secondary standard. The Committee recommended that the WHO Collaborating Centre for Chemical Reference Substances should conduct a follow-up exercise and report on its results at the next meeting of the Expert Committee.

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