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Method for Microbiological Testing of Nonsterile Pharmaceuticals

机译：非无菌药物的微生物学检验方法

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摘要

A method for testing nonsterile pharmaceutical preparations for their microbial content is described. As far as possible, only solid culture media were used to obtain quantitative results. Aqueous and water-soluble products were tested with membrane-filter techniques. Nonfilterable products were first emulsified or suspended and the homogenate was used for examination. In both procedures, the total number of colonies is determined for aerobic bacteria and fungi. Tests for certain undesirable microbial groups were conducted with selected media. The method described is applicable for finished products, bulk products, raw materials, and active ingredients.
机译：描述了一种测试非无菌药物制剂的微生物含量的方法。尽可能仅使用固体培养基获得定量结果。水性和水溶性产品通过膜滤技术进行测试。首先将不可过滤的产品乳化或悬浮，然后将匀浆物用于检查。在这两种方法中，确定好氧细菌和真菌的菌落总数。使用选定的培养基对某些不良微生物进行了测试。所描述的方法适用于成品，散装产品，原材料和活性成分。

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