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重组人促红细胞生成素检定
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重组人促红细胞生成素检定
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医学
重组人促红细胞生成素检定
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testing for recombinant human erythropoietin
重组人促红细胞生成素检定
为确保产品质量,应用高效液相色谱仪、电泳仪、分光光度仪、酶标仪等专有仪器设备,依据药品质量标准,采用适当的检验方法和标准物质,对应用重组脱氧核糖核酸(DNA)技术制备的促红素的理化性质、含量、生物学活性、纯度、杂质及安全性等各类检验项目进行检测分析,以确定其是否符合药品标准规定的检验工作。是保证重组人促红素药物安全、有效、质量可控的重要环节。
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