WHO TRS (Technical Report Series) 953, 2009 Annex 1

Sathyanarayana M.Sc.

WHO TRS (Technical Report Series) 953, 2009 Annex 1

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

General information:

International Chemical Reference Substances 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 medicines published in The International Pharmacopoeia or proposed in draft monographs. International Chemical Reference Substances are mainly intended to be used as primary standards to calibrate secondary standards.

Directions for use and required analytical data for the intended use in the relevant specifications of 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 this use.

It is generally recommended that the substances should be stored protected from light and moisture and preferably at a temperature of about +5 °C. When special storage conditions are required, this is stated on the label or in the certificate. It is recommended to the user to purchase only an amount sufficient for immediate use.

The stability of the International Chemical Reference Substances kept at the Collaborating Centre is monitored by regular re-examination and any material that has deteriorated is replaced by new batches when necessary. Lists giving control numbers for the current batches are issued in the annual reports from the Centre and new lists may also be obtained on request.

See the pdf file for complete details:

WHO TRS (Technical Report Series) 953, 2009 Annex 1:

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