Collaborative study for the establishment of the 3rd international standard for dihydrostreptomycin.

Q4 Medicine Pharmeuropa bio & scientific notes Pub Date : 2012-04-01
G Rautmann, A Daas, K-H Buchheit
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引用次数: 0

Abstract

An international collaborative study was organised to establish the World Health Organization (WHO) 3rd International Standard (IS) for dihydrostreptomycin. Eleven laboratories from different countries participated in the collaborative study. The potency of the candidate batch, a freeze-dried preparation, was estimated by microbiological assays with sensitive microorganisms. To ensure continuity between consecutive batches of the WHO IS, the 2nd IS for dihydrostreptomycin was used as standard. Based on the results of the study, the 3rd IS for dihydrostreptomycin was adopted at the meeting of the WHO Expert Committee on Biological Standardisation (ECBS) in 2011 with an assigned anti-microbiological activity of 19425 International Units (IU) per vial. The 3rd IS for dihydrostreptomycin is available from the EDQM.

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二氢链霉素第三项国际标准的制定合作研究。
组织了一项国际合作研究,以制定世界卫生组织(世卫组织)关于双氢链霉素的第三个国际标准。来自不同国家的11个实验室参与了这项合作研究。冻干制剂候选批的效力是通过敏感微生物的微生物测定来估计的。为保证连续批次WHO IS的连续性,以第二批WHO IS为标准。根据研究结果,2011年世卫组织生物标准化专家委员会会议通过了双氢链霉素的第三个标准,规定每瓶抗微生物活性为19425国际单位(IU)。二氢链霉素的第三个IS可从EDQM获得。
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来源期刊
Pharmeuropa bio & scientific notes
Pharmeuropa bio & scientific notes Medicine-Medicine (all)
CiteScore
0.70
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0.00%
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0
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