(1999; 168 pages) [Spanish]
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.