Certificates of analysis: a challenge to interpret

Abstract : The active pharmaceutical ingredient (API) in a medicinal product is the component that is responsible for the therapeutic effect. The personnel at the ANSES Fougères Laboratory routinely handle medicinal analytical standard and calculate their API content using the certificates of analysis provided by the manufacturer. However, meaningful data in these documents are not always easy to determine or may sometimes be absent: interpretation of these data can therefore result in assessment errors. Having identified this problem, the ANSES Laboratory has put forward an approach aimed at harmonising interpretation of certificates of analysis.