Search results - 38 results
Clustering of Tadalafil API Samples According to their Manufacturer in the Context of API Falsification Detection
Official Medicines Control Laboratory Network (GEON), on tadalafil. A classical market surveillance study, evaluating compliance to the European Pharmacopoeia, was combined with a fingerprint study, the ...
GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples
the Quality of Medicines & HealthCare (EDQM), regularly organises market surveillance studies for specific API s for conformity to their monograph in the European Pharmacopoeia. During the past ...
European fingerprint study on omeprazole drug substances using a multi analytical approach and chemometrics as a tool for the discrimination of manufacturing sources
substances and prevent the use of non-compliant API s, Official Medicine Control Laboratories work together in a European network developing coordinated strategies and programmes. The API working group ...
Characterization and risk identification of falsified medicines and adulterated dietary supplements
selectivity and specificity for the detection of targeted plants in mixtures. It stands to reason that collaborations on these topics would be beneficial for both the European and the Chinese policy makers to ...
Characterization and hazard identification of substandard and falsified antimicrobials encountered in Belgium
characterization of SF-antimicrobials, collected samples were also evaluated in terms of impurities and dissolution. The impurities were analyzed based on the methods of the European Pharmacopoeia (Ph. Eur.) and the ...
API Testing: how OMCLs can support the control of APIs
Publication Type: Scientific poster, presentation or proceeding Authors: Eric Deconinck; Yvan Grange Source: EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow’s Medicines, EDQM, ...
A simple dilute-and-shoot method for screening and simultaneous quantification of nicotine and alkaloid impurities in electronic cigarette refills (e-liquids) by UHPLC-DAD
quality control of nicotine related impurities, for which the European Pharmacopoeia limits are currently applied, the sensitivity of the UHPLC- DAD method was found to be within the acceptable range. ...
Report on the collaborative study for the standardization of D-Ag potency assays for inactivated polio vaccines made with Sabin live-attenuated poliovirus strains
Keywords: biological reference preparation collaborative study D antigen European Pharmacopoeia in vitro assay poliomyelitis vaccine (inactivated) Health Topics: Infantile paralysis Kinderverlamming ...
European Pharmacopoeia biological reference preparation for poliomyelitis vaccine (inactivated)
Bio&SN, Issue December, Number 149, Strasbourg, France, p.16 (2016) Accession Number: NA Keywords: poliomyelitis vaccine (inactivated); D antigen; biological reference preparation; European Pharmacopoeia ...
Collaborative study for the establishment of the WHO 3rd international standard for Endotoxin, the Ph. Eur. endotoxin biological reference preparation batch 5 and the USP Reference Standard for Endotoxin Lot H0K354
(2nd) IS, as well as new European Pharmacopoeia (Ph. Eur.). and USP standards. The suitability ofthe candidate preparations to act as the reference standard in assays for endotoxin performed according to ...