TY - JOUR T1 - European fingerprint study on omeprazole drug substances using a multi analytical approach and chemometrics as a tool for the discrimination of manufacturing sources JF - Journal of Pharmaceutical and Biomedical Analysis Y1 - 2022 A1 - H. Rebiere A1 - Y. Grange A1 - Eric Deconinck A1 - Patricia Courselle A1 - J. Acevska A1 - K. Brezovska A1 - J. Maurin A1 - T. Rundlöf A1 - M.J. Portela A1 - L.S. Olsen A1 - C. Offerlé A1 - M. Bertrand KW - Chemometrics KW - Data fusion KW - fingerprint KW - OMCL network KW - Omeprazole API KW - Substandard and falsified products AB -

Like drug products, Active Pharmaceutical Ingredients (APIs) are subject to substandard and falsification issues, which represent a threat to patient health. In order to monitor the quality of drug substances and prevent the use of non-compliant APIs, Official Medicine Control Laboratories work together in a European network developing coordinated strategies and programmes. The API working group proposed a market surveillance study on omeprazole and omeprazole magnesium with the objectives of controlling the pharmaceutical quality of samples, checking compliance with the monographs of the European Pharmacopoeia, and collecting analytical fingerprints that could be further used to differentiate manufacturing sources for future authenticity investigations. The study described in this article reports the analysis carried out by 7 European laboratories on 28 samples from 11 manufacturers with 5 analytical techniques (related substances with HPLC, residual solvents with GC-MS, near infrared spectroscopy, proton nuclear magnetic resonance spectroscopy and X-ray powder diffractometry). The large amount of resulting analytical data were centralized and treated with two chemometric methods: Principal Component Analysis and Hierarchical Clustering Analysis. Data were analyzed separately and in combination (data fusion), allowing us to conclude that NMR and XRPD were suitable to differentiate samples originating from 9 out of 11 manufacturers. Analytical fingerprints associated with chemometrics were demonstrated to be a valuable methodology to discriminate manufacturers of omeprazole and omeprazole magnesium APIs and detect future substandard and falsified APIs.

VL - 208 M3 - 10.1016/j.jpba.2021.114444 ER -