WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report: 3. International Chemical Reference Substances and International Infrared Reference Spectra: 3.1. Establishment of reference substances

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages)

Table of Contents

	WHO Expert Committee on Specifications for Pharmaceutical Preparations
	1. Introduction
	2. The international pharmacopoeia and related activities
		2.1. Quality specifications for drug substances and dosage forms
		2.2. Dissolution test for solid oral dosage forms: paddle method
		2.3. Therapeutic equivalence of multisource products
		2.4. International nonproprietary names for pharmaceutical substances
	3. International Chemical Reference Substances and International Infrared Reference Spectra
		3.1. Establishment of reference substances
		3.2. Infrared reference spectra
	4. Quality control methods for medicinal plant materials
	5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
	6. Good manufacturing practices for pharmaceutical products
		6.1. Biological products
		6.2. Herbal medicinal products
		6.3. Process validation
		6.4. Further developments
	7. Development of globally acceptable standards for excipients
	8. Stability of dosage forms
		8.1. Survey
		8.2. Guidelines on stability testing of pharmaceutical products containing established drug substances
	9. Simple test methodology
	10. Quality assurance in pharmaceutical supply systems
	11. Pharmaceutical production in developing countries
		11.1. Small-scale preparation of ophthalmic (eye) drops
		11.2. Production of hormonal contraceptives
	12. Training
	Acknowledgements
	References
	Annex 1 - List of available International Chemical Reference Substances¹
	Annex 2 - List of available International Infrared Reference Spectra
	Annex 3 - Good manufacturing practices for biological products¹
		1. Scope of these guidelines
		2. Principles
		3. Personnel
		4. Premises and equipment
		5. Animal quarters and care¹
		6. Production
		7. Labelling
		8. Lot processing records (protocols) and distribution records
		9. Quality assurance and quality control
		Authors
		Acknowledgements
		References
	Back 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.