中国药典、欧洲药典和美国药典中头孢噻肟钠原料质量控制标准与方法的比较

Comparison of Standards and Methods for the Quality Control of Cefotaxime Sodium in Chinese Pharmacopoeia,European Pharmacopoeia and United States Pharmacopoeia

文章比较了中国药典、欧洲药典和美国药典中对头孢噻肟钠原料质量控制标准与方法的异同,重点比较了含量测定和有关物质检查中的高效液相色谱法,初步讨论了规定条件下的色谱柱选择与使用问题。

The paper compared the quality control standards and methods of cefotaxime sodium in Chinese Pharmacopoeia,European Pharmacopoeia and United States Pharmacopoeia,and mainly compared the high performance liquid chromatography of the assay and related substances test.The selection and problems of HPLC columns in standard conditions were discussed too.