The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted two market surveillance studies on omeprazole and sildenafil, the results of which have been published in the Journal of Pharmaceutical and Biomedical Analysis, Vol. 208 (2021) (doi:10.1016/j.jpba.2021.114444), and the journal Talanta, 239 (2022) (doi:10.1016/j.talanta.2021.123123), respectively.
In these studies, Official Medicines Control Laboratories (OMCLs) tested the pharmaceutical quality of samples, checked compliance with the monographs of the European Pharmacopoeia and used chemometric methods to process analytical fingerprints. These fingerprints could then be used to differentiate between manufacturing sources in future authenticity investigations.
An API fingerprint is a specific analytical profile that includes information on the physico-chemical properties of the substance. API fingerprint studies are performed in order to identify substandard or falsified APIs, which represent a threat to patient health.
More information on chemometric methods are available in the GEON document “Benefits of Chemometrics for OMCLs”.