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聚乙二醇400微生物限度检查方法学验证

Author(s)：
车亚云

Publication Title：

Wen Yuan (Middle School Edition) 2021 No.12

Affiliations：
南京威尔药业集团股份有限公司江苏南京 210000

Abstract：
根据《中国药典》2020版四部聚乙二醇400的特性制订检验方法和检验条件，按制定的方法进行试验，根据验证结果判断是否符合验证标准。若符合，按验证的方法和条件进行聚乙二醇400产品的微生物限度检查；若不符合，重新建立制订检验方法和检验条件，再进行验证，直至验证结果符合设立的验证标准。

Keywords：
聚乙二醇400；微生物限度检查；培养

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[1] 车亚云.聚乙二醇400微生物限度检查方法学验证[J].Wen Yuan (Middle School Edition),2021(12),.

文渊(中学版)

Wen Yuan (Middle School Edition)

Language: 中文

CN：11-9275/G

ISSN：2096-627X

Publication Frequency: 月刊

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