WHO TRS (Technical Report Series) 917 Annex 1

Lists of available International Chemical Reference Substances and International Infrared Reference Spectra

1. International Chemical Reference Substances:

International Chemical Reference Substances (ICRS) are established upon the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for use in physical and chemical tests and assays described in the specifications for quality control of drugs published in The International Pharmacopoeia or proposed in draft monographs. The International Chemical Reference Substances are mainly intended to be used as primary standards to calibrate secondary standards.

Directions for use and the analytical data required for the tests specified in The International Pharmacopoeia are given in the certificates enclosed with the substances when distributed.

International Chemical Reference Substances may also be used in tests and assays not described in The International Pharmacopoeia. However, the responsibility for assessing the suitability of the substances then rests with the user or with the pharmacopoeia commission or other authority that has prescribed the use of these substances.

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WHO TRS (Technical Report Series) 917 Annex 1: