Search results - 9 results

Characterization of a Bacteriophage GEC_vB_Bfr_UZM3 Active against.

represent a strictly lytic phage belonging to a siphovirus morphotype. It is characterized by high stability at body temperature and in pH environments for about 6 h. Whole genome sequencing analysis of the ...

The GEONs API-fingerprint program: Tackling falsifications of APIs

atypical market surveillance studies (MSS), where an MSS (analysis according to the Ph. Eur.) is combined with a fingerprint study (MSSFP). An MSS, according to Ph. Eur. only gives an indication of the ...

Guideline for Pandemic COVID-19 Vaccine (mRNA)

PA/PH/OMCL (22) 86 DEF Keywords: EDQM mRNA OCABR vaccine Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, ...

Guideline for Pandemic COVID-19 Vaccine (Non-replicating Adenovirus-vectored vaccine)

PA/PH/OMCL (21) 29 DEF Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments et produits de santé- ...

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 ...

Ontwikkeling van een HILIC-PDA methode voor de detectie van illegale polypeptiden

ammoniumformaat 80% acetonitrille (ACN) oplossing met pH 3 en een 10 mM ammoniumformaat 40% ACN oplossing met pH 3 aangewend. Aangezien humane insuline, runder- en varkensinsuline in een 80% ACN oplossing niet of ...

Release testing by manufacturers & Ph.Eur. compliance: lessons learnt for competent authorities. A case study: the Extractable Volume

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle; Geneviève Waeterloos Source: Annual OMCL meeting, NA, Issue EDQM, NA (2012) Keywords: a Case case studies Case study case-study compliance meeting Release testing stud ...

Establishment of the Ph. Eur. BRP for varicella vaccine batch 1.

Antibodies, Viral Chickenpox Vaccine Europe Freeze Drying Herpesvirus 3, Human Humans Pharmacopoeias as Topic Reference Standards Reproducibility of Results Abstract: The European Pharmacopoeia (Ph. Eur.) ...

Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein)

PA/PH/OMCL (21) 89 DEF Keywords: COVID-19 OCABR vaccine Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, ...

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