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
 
6.4 Information to be supplied with chemical reference substances

Labels on chemical reference substances should give the following information:

- the appropriate name of the substance: the international nonproprietary name (INN) should be used wherever possible;

- name and address of the issuing body;

- approximate quantity of material in the container; and

- batch or control number.

Where associated documents are provided they should incorporate relevant items from the list above. The following information should be given, as necessary, on the labels and/or in associated documents:

- recommended storage conditions (if special conditions apply);

- intended use of the chemical reference substance;

- directions for use (e.g. storage and handling);

- information about assigned analytical value of the chemical reference substance (needed for calculation of the results of tests in which the substance will be used);

- a disclaimer of responsibility when chemical reference substances are misused, or stored under inappropriate conditions, or used for other purposes than those intended by the issuing body; and

- health hazard information or warning in conformity with national and regional regulations or international agreements.

If analytical data are to be supplied with the chemical reference substances, it is recommended that the data provided be limited to what is necessary for the proper use of the substances in the tests and assays.

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Last updated: May 3, 2013