The strategic change of the API fingerprint programme: from verification of authenticity of API sources to identifying potential quality issues

Last updated on 15-5-2024 by Eric Deconinck

Scientific poster, presentation or proceeding




Since its creation the API-surveillance programme, performed under the hospices of the API-working group, focused a lot on the authenticity of APIs and the detection of falsified or substandard ones, due to the risks related to the quality of the finished product. With this vision the fingerprint programme was created, where next to conformity analysis to Ph. Eur. Monographs, other types of analysis were performed in order to obtain data, allowing to distinct the different API samples according to their origin or manufacturer. The idea was to obtain a “fingerprint” of the different manufact…

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