Zoekresultaten - 33 results

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

reference preparation collaborative study D antigen European Pharmacopoeia in vitro assay poliomyelitis vaccine (inactivated) Health Topics:  Infantile paralysis Kinderverlamming Service:  Qualité des vaccins ...

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 ...

Pre-registration efficacy study of a novel marker vaccine against classical swine fever on Maternally Derived Antibody negative (MDA-) target animals.

candidate CP7_E2alf produced under Good Laboratory Practice (GLP) conditions by Pfizer was tested on 40 six-week-old MDA-piglets according to the European Pharmacopoeia (Ph.Eur.) requirements. Single doses of ...

Collaborative study for the calibration of the Ph. Eur. prekallikrein activator in albumin BRP batches 4, 5 and 6

collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to calibrate replacement batches for thecurrent European Pharmacopoeia (Ph. ...

Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3

Medicine medicines method performance ph Quality result results STANDARD study use Users vaccine WHO Abstract: The current hepatitis A vaccine (HAV), inactivated, non-adsorbed, European Pharmacopoeia (Ph. ...

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