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
Close this folder3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document3.1. Establishment of reference substances
View the document3.2. 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
 

3.1. Establishment of reference substances

Five new1 International Chemical Reference Substances were adopted by the Committee according to the procedure described in the thirty-second report. It was noted that replacement batches had been introduced for four2 previously established Reference Substances.

1 Amphotericin B, erythromycin, nystatin, rifampicin, sulfasalazine.
2p-Acetamidobenzalazine, ampicillin (anhydrous), ethinylestradiol, retinol (vitamin A) acetate.


The total collection now comprises 152 International Chemical Reference Substances and 13 Melting Point Reference Substances (Annex 1). The Committee took note of information concerning the International Chemical Reference Substances supplied to different WHO regions and countries. It suggested that, when information was sought on the use of The international pharmacopoeia, as mentioned in section 2.1, those questioned should also be asked to comment on the use of reference substances.

The Committee reiterated that, as pointed out at the thirty-second meeting (3), there was a need to revise and extend the recommendations included in the “General guidelines for the establishment, maintenance, and distribution of chemical reference substances” originally issued in 1982 (4).

The Committee recommended that, for those substances where an International Chemical Reference Substance existed in parallel with an International Biological Standard (5), it should be decided on a case-by-case basis whether both reference materials were necessary. Such decisions would need to be taken jointly by the present Committee and the WHO Expert Committee on Biological Standardization. As a first step, discussions should take place between the WHO Collaborating Centre for Chemical Reference Substances, Stockholm, Sweden and the relevant International Laboratory for Biological Standards, taking into account the intended use of the relevant standards.

The Committee expressed its appreciation to the WHO Collaborating Centre for Chemical Reference Substances for its work and to the National Corporation of Swedish Pharmacies for its continued financial support for the WHO programme on International Chemical Reference Substances.

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