(1997; 248 pages) [French]
4.3 Information to be supplied with reference substances
Some centres for reference materials supply extensive documentation with the reference substances, and include directions for use. Other centres supply no information except the name of the substance and of the issuing authority. Such differing practices may result in improper use of the reference substances. It is desirable that recommendations should be made concerning the information to be supplied with reference substances and its manner of expression.
Labels on chemical reference substances should give the following information:
(a) name of the substance;
(b) type of reference substance (e.g. International Chemical Reference Substance, or National Chemical Reference Substance, or Authentic Specimen);
(c) name and address of the issuing authority;
(d) approximate quantity of material in the container; and
(e) batch or control number.
The following information should be given, as necessary, either on the labels or in associated documents:
(i) recommended storage conditions (if special conditions apply, these should be given on the label);
(ii) intended use of the reference substances;
(iii) directions for use (e.g. instructions about drying the material before use and any necessary cautionary statements);
(iv) information about the composition of the reference substance, which is needed for calculation of the results of tests in which the substance will be used; and
(v) a disclaimer of responsibility when reference substances are misused, or stored under inappropriate conditions, or used for other purposes than those intended by the issuing authority.
It is recommended that the analytical data given in the certificates supplied with the reference substances should be restricted to what is necessary for the proper use of the substances in the tests and assays for which they are provided. The full analytical reports, should, however, be available when needed for evaluation of the suitability of the reference substances for uses other than those originally intended. It might also be desirable to give more general information about the reference substances concerned, either on separate leaflets or incorporated in the certificates.