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中国药典2020版标准分析人血白蛋白多聚体 KW-803

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最后更新: 2024-01-15 11:04
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《中国药典》2020版第四部规定,使用高效液相色谱法分析人血白蛋白多聚体,指定的色谱柱要求为:亲水硅胶高效体积排阻色谱柱(SEC,排阻极限300 kD,粒度10 μm),柱直径7.5 mm, 长60 cm (注1) 。药典中要求,人血白蛋白单体峰与二聚体峰间的分离度应大于1.5,拖尾因子按人血白蛋白单体峰计算应为0.951.40。使用PROTEIN KW-803色谱柱进行分析,可以满足药典的各种要求。

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注1:《中国药典》2020版规定,色谱柱的内径与长度,填充剂的形状、粒径与粒径分布、孔径、表面积、键合基团的表面覆盖度、载体表面基团残留量,填充的致密与均匀程度等均影响色谱柱的性能,应根据被分离物质的性质来选择合适的色谱柱。


Sample : 20 ?L
Human serum albumin 12 mg/mL
1. Dimer
2. Monomer

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portant;">Column : Shodex PROTEIN KW-803 (8.0 mm I.D. x 300 mm) Eluent : 0.5 M NaH2PO4aq./0.5 M Na2HPO4aq./Isopropanol/H2O=200/420/15.5/914.5 Flow rate : 0.6 mL/min Detector : UV (280 nm) Column temp. : 30 ℃

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