| Collaborative study for the establishment of the third international standard for nystatin. | |
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MedLine Citation:
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PMID: 21144490 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Due to the depletion in stocks of the World Health Organization (WHO) 2nd International Standard (IS) for nystatin, an international collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to establish a replacement batch. Seventeen laboratories participated in the collaborative study, performing the microbiological diffusion assay to estimate the potency of the candidate 3rd International Standard for nystatin. The 2nd International Standard for nystatin was used as a standard to ensure the continuity of the unitage. Follow-up accelerated degradation studies demonstrated that the IS is stable when at the customary storage temperature of - 20 °C. The 3rd IS for nystatin was adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2006 with an assigned potency of 5710 International Units per mg (IU/mg). The 3rd IS for nystatin is available from the EDQM. |
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Authors:
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G Rautmann; E Charton; A Daas; K-H Buchheit |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Pharmeuropa bio & scientific notes Volume: 2010 ISSN: 2075-2164 ISO Abbreviation: Pharmeur Bio Sci Notes Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-12-14 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101510163 Medline TA: Pharmeur Bio Sci Notes Country: France |
Other Details:
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Languages: eng Pagination: 68-85 Citation Subset: IM |
Affiliation:
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European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France. guy.rautmann@edqm.eu. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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