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Konzepte der Content Uniformity-Prüfungen in den Arzneibüchern einschließlich des neuen, harmonisierten (ICH) Tests

Roland Schorr¹, Rüdiger Gössl² und Heribert Häusler³

Boehringer Ingelheim Pharma GmbH & Co. KG, A Launch Production¹, A Medical Data Services²,
A Quality Operations³, Ingelheim/Rhein

Korrespondenz: Dr. Roland Schorr, Boehringer Ingelheim Pharma GmbH & Co. KG, A Launch Production/Prozeßentwicklung Pharmaherstellung, 55216 Ingelheim am Rhein (Germany), e-mail: Roland.Schorr@ing.boehringer-ingelheim.com

Concepts of Compendial Content Uniformity Tests including the New Harmonized (ICH) Test

An overview is presented on the principles governing compendial content uniformity tests. Special consideration has been given to the harmonized Dose Uniformity Test recently introduced by the ICH (International Conference on Harmonization). The traditional European Pharmacopoeia Content Uniformity Test by using a non-parametric scheme differs considerably from the Content Uniformity Tests described by the USP, JP or ICH, which basically all use a parametric approach. In cases where batches show poor homogeneity or deviating assay values, lower acceptance probabilities will result for European pharmaceutical companies when applying the new ICH-test.

Key words Arzneimittelherstellung • Content Uniformity-Prüfung • Europäisches Arzneibuch • ICH-Test