Verunreinigungen in pharmazeutischen Produkten Christian Zeine LGC Promochem GmbH, Wesel Korrespondenz: Dr. Christian Zeine, LGC Promochem GmbH, Mercatorstr. 51, 46485 Wesel (Germany), e-mail: christian.zeine@lgcpromochem.com Impurities in drug products Impurities are always present in drug products in trace quantities. Limit and threshold values are provided by official bodies, i.e. pharmacopoeias and ICH (their guidelines). Dedicated reference standards for impurities can help in development and validation of analytical methods for impurity control, and are also used in the routine analysis of drug products. The use of such standards can also prevent cost and time intensive qualification studies according to ICH guidelines (e.g. by animal experiments). Key words Analysenzertifikat • Guidelines • ICH-Leitlinien • Referenzstandards • Verunreinigungen |
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