Document Detail


Collaborative study for the establishment of the second international standard for vancomycin.
MedLine Citation:
PMID:  22225764     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
An international collaborative study has been organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish the World Health Organization (WHO) 2nd International Standard (IS) for Vancomycin. Twelve laboratories from 10 different countries participated. The potency of the candidate material, a freeze-dried preparation, was estimated by microbiological assays with sensitive micro-organisms. As the stocks of the 1st IS for Vancomycin had been completely depleted, in order to ensure continuity between consecutive batches of the WHO IS, the European Pharmacopoeia Chemical Reference Standard (CRS) for Vancomycin batch 2 was used as a standard. It had been calibrated in a large international collaborative study against the WHO 1st IS for Vancomycin. Based on the results of the study, the 2nd IS for Vancomycin was adopted at the meeting of the WHO Expert Committee on Biological Standardisation (ECBS) in 2010 with an assigned antimicrobiological activity of 109 700 IU per vial. The 2nd IS for Vancomycin is available from the EDQM.
Authors:
G Rautmann; A Daas; K-H Buchheit
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pharmeuropa bio & scientific notes     Volume:  2011     ISSN:  2075-2164     ISO Abbreviation:  Pharmeur Bio Sci Notes     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2012-01-09     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101510163     Medline TA:  Pharmeur Bio Sci Notes     Country:  France    
Other Details:
Languages:  eng     Pagination:  1-15     Citation Subset:  IM    
Affiliation:
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France. guy.rautmann@edqm.eu.
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