The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted a market surveillance study on tadalafil, the results of which have been published in the Journal of Pharmaceutical Sciences, Vol. 112 (2023).
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 might represent a threat to patient health.
In the study, OMCLs tested the pharmaceutical quality of samples, checked compliance with the monograph of the European Pharmacopoeia and used chemometric methods to establish analytical fingerprints. These fingerprints may then be used to differentiate between manufacturing sources in future authenticity investigations.
You can find out more about chemometric methods in the GEON document “Benefits of Chemometrics for OMCLs”.
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