Zoekresultaten - 3 results
Characterisation and Hazard identification of substandard and Falsified Antimicrobial Drugs. The CantiBio project 2016-2020
methods of the European Pharmacopoeia (Ph. Eur.) and the dissolution methods were adopted from the United States Pharmacopeia (USP). Moreover, the dissolution profiles of SF antimicrobials were compared to ...
The strategic change of the API fingerprint programme: from verification of authenticity of API sources to identifying potential quality issues
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 ...
OMCL testing and the API working group: Part of the solution?
of API s is real and was shown by several crisis. Therefore the API- WG organizes atypical market surveillance studies (MSS), where an MSS (analysis according to the Ph. Eur.) is combined with ...