Report concerning the colaborative study for establish of reference standard eficacity of Rifamycin
The Microbiology Laboratory from the Institute for the Control of Veterinary Biological Products and Medicines participated in a collaborative study in order to determine the potency of rifamycin CRS, batch 4, according to the protocol sent by the EDQM (European Directorate for the Quality of Medici...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Asociaţia Naţională a Fabricanţilor de Produse de Uz Veterinar
2015-12-01
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| Series: | Medicamentul Veterinar |
| Online Access: | http://www.veterinarypharmacon.com/docs/1600-2015_VD2_Art.8_ENG..pdf |
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| Summary: | The Microbiology Laboratory from the Institute for the Control of Veterinary Biological Products and Medicines participated in a collaborative study in order to determine the potency of rifamycin CRS, batch 4, according to the protocol sent by the EDQM (European Directorate for the Quality of Medicines) - coordinating of the study. The purpose of the study was to establish the potency of the batch 4 rifamycin in the characterization of the substance as reference standard. Potency was determined by
microbiological method, based on comparison of the inhibition zones of growth of micro-organisms sensitive to those of a reference standard, as specified in European Pharmacopoeia, Chapter 2.7.2. - Microbiological testing of antibiotics. After analysis of received data from participants and their statistical processing by the EDQM, the potency of the batch 4, rifamycin - reference materials, was established in 870 UI/mg. |
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| ISSN: | 1843-9527 2069-2463 |