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
 

3.1 Establishment of International Chemical Reference Substances

Twenty-eight new International Chemical Reference Substances1 were adopted by the Committee according to the procedure described in the thirty-second report (8). It was reported that the depleted stock of benzil, a melting point reference substance, had been replaced with a new batch. The total collection now comprises 193 chemical reference substances and 12 melting point reference substances (Annex 1). The Committee was informed that, in accordance with the general guidelines for the establishment, maintenance and distribution of chemical reference substances (see section 3.4 and Annex 3) and the principles of good manufacturing practices (GMP), each International Chemical Reference Substance would now be accompanied by a signed certificate.

1 Amidotrizoic acid, 3-amino-2,4,6-triiodobenzoic acid, benzil, betamethasone sodium phosphate, calcium folinate, chloroquine sulfate, doxorubicin hydrochloride, erythromycin B, erythromycin C, flucloxacillin sodium, fludrocortisone acetate, gentamicin sulfate, hydrocortisone sodium succinate, levonorgestrel, loperamide hydrochloride, mebendazole, methotrexate, nifurtimox, paracetamol, paromomycin sulfate, praziquantel, prednisolone hemisuccinate, prednisolone sodium phosphate, sulfacetamide, tamoxifen citrate, tamoxifen citrate E-isomer, testosterone enantate, toluene-2-sulfonamide.

 

It was suggested that, to avoid unnecessary delays in making newly established chemical reference substances available, a procedure of approval by correspondence might be considered as an interim measure between meetings of the Committee.

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 to the WHO programme on International Chemical Reference Substances.

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