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Standards Development
This document specifies the interpretation of the certificates of analysis (CoA) supplied by the manufacturers of analytical reference standards (ARS) (e.g. veterinary medicines, pesticides, food additives) and accompanying each lot of raw material used as a reference substance.
The goals of this document are to facilitate and to harmonise the interpretation of CoA in order for all stakeholders to have full trust in the results of their analytical methods.
It describes the methods for calculating the content of the active (pharmaceutical) ingredient (API) in analytical reference standards:
— by calculating the chemical substance (CS) content in the analytical reference standard (ARS),
— by calculating the water content in the analytical reference standard (ARS),
— and if necessary by calculating the active ingredient (AI) content in the chemical substance (CS).
A spread sheet can be used to calculate the AI content with the indications given in the certificate of analysis, and if necessary those of other documents (pharmacopoeia, Merck Index, ...).
This document is intended to be useful for manufacturers and suppliers of analytical reference standards, laboratories developing and validating analytical methods or tests, competent authorities and dairies or end users of analytical reference standards or tests for the detection of veterinary drug residues in milk products.
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