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质量控制实验室第6章：标准物质管理.pdfVIP

质量控制实验室第6章：标准物质管理.pdf

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    GMP指南1300问

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    2023GMP指南

    质量控制实验室第6章

    标准物质管理

    李万里

    1

    质量控制实验室第6章：标准物质管理

    ●一、法规介绍··················································································································································································5

    ●问1：该章主要介绍了哪些内容？····················································································································································5

    ●问2：有哪些法规要求？····································································································································································5

    ●二、理化检测用标准物质·························································································································································5

    ●问3：什么是理化检测用标准物质？················································································································································5

    ●问4：理化检测用标准物质分类方法和种类有哪些？····················································································································5

    ●问5：什么是含量测定用化学对照品？············································································································································5

    ●问6：什么是鉴别或杂质检查用化学对照品？································································································································5

    ●问7：什么是对照药材/对照提取物？··············································································································································5

    ●问8：什么是校准仪器/系统适用性试验用对照品？······························································

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