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Résultats de la recherche - 4 results
Clustering of Tadalafil API Samples According to their Manufacturer in the Context of API Falsification Detection
falsified samples. In total, 46 tadalafil API samples from 13 different manufacturers were collected. For all samples fingerprint data was collected through analysis of impurities and residual solvents, mass ...
GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples
chromatography for residual solvents, X-ray diffraction and Nuclear Magnetic Resonance (NMR) spectroscopy. Chemometrics applied to the collected data showed that all manufacturers could be discriminated based on ...
European fingerprint study on omeprazole drug substances using a multi analytical approach and chemometrics as a tool for the discrimination of manufacturing sources
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, ...
Impurity profiling of the most frequently encountered falsified polypeptide drugs on the Belgian market
API-related impurities, small molecule contaminants (defined as organic small molecules not belonging to the other categories), elemental impurities and residual solvents. This comprehensive study showed that ...