Reference Substances and Infrared Reference Spectra for Pharmacopoeial Analysis (WHO Technical Report Series, No. 885, 1999: Annex 3)
(1999; 117 pages)
Table of Contents
View the documentPreface1
Open this folder and view contents1. Compilation of national, regional and international reference substances and infrared reference spectra
Close this folder2. General guidelines for the establishment, maintenance and distribution of chemical reference substances - Reprint from WHO Technical Report Series, No. 885, 1999: Annex 3
View the documentIntroduction
Close this folderPart A. Primary chemical reference substances
View the document1. Assessment of need for the establishment of chemical reference substances
View the document2. Obtaining source material
Open this folder and view contents3. Evaluation of chemical reference substances
Open this folder and view contents4. Chemical and physical methods used in evaluating chemical reference substances
View the document5. Assignment of content
Close this folder6. Handling and distribution of chemical reference substances
View the document6.1 Packaging operations
View the document6.2 Storage
View the document6.3 Stability
View the document6.4 Information to be supplied with chemical reference substances
View the document6.5 Distribution and supply
View the document6.6 Period of use
View the documentPart B. Secondary chemical reference substances
View the documentReferences
View the documentBack cover
 
6.6 Period of use

Chemical reference substances do not carry an “expiry date” in the conventional sense. To avoid the unnecessary discarding of satisfactory substances, a mechanism for general control of the batch of a chemical reference substance may be used by the issuing body. If the issuing body applies stability considerations and a monitoring procedure based on its experience to its collection, this should guarantee the user of the acceptability of the chemical reference substance for its intended use.

If it is considered necessary to specify a beyond-use date, it should be stated on the label and/or on a document accompanying the chemical reference substances. Adequate shipping records should exist to enable contact with the purchaser of a batch for recall or other notification.

The storage and maintenance of unopened containers of the chemical reference substance in accordance with information provided are integral to its suitability of use. To avoid potential doubts concerning the integrity of opened containers, it is suggested that potential users obtain only the quantities of substances necessary for short-term need and obtain fresh stocks (held under controlled and known conditions) when needed. Long-term storage of substances in opened containers is to be avoided. Similarly, efforts should be made to avoid possible degradation, contamination and/or introduction of moisture during the repeated use of a substance.

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Last updated: April 24, 2012