Forensic Analysis of Compendial Articles: The Tightening Noose, EDQM, USPC, Anticipated Fallouts

摘要

The inclusion of impurity control as a requirement by ICH (Q3 topic) necessitated testing and characterisation of minutiae in new drugs by the pharmaceutical industry. This concept of forensic analysis of pharmaceuticals has even penetrated into the compendial monographs. The recently introduced monographs on active substances in European Pharmacopoeia (Ph. Eur.) contain a separate test for Related Substances, apart from the Assay procedure, mostly involving HPLC separation of drug and impurities. Similarly, the United States Pharmacopeia (USP) has a parallel test under the head 'Chromatographic Purity', different to Assay. Some recent developments have provoked compendial authorities to re-think over the currently existing requirements for control of impurities. The same is expected to change the scenario in every laboratory connected with Pharmacopoeial testing. An expected fallout is a manifold increase in the cost of testing, and eventually the prices of not only the new drugs but even the existing ones.