【摘 要】
：
目的:通过不同的称样量对注射用氨甲环酸含量的影响,来验证所采用的分析方法的科学性、准确性和可行性.方法:取三批次注射用氨甲环酸产品,采用不同的称样量、不同的检验人员、液相所测得的含量结果等数据进行比对;通过重复性试验、中间精密度来进一步进行论证.结论:非水滴定法样品的称样量对于注射用氨甲环酸含量测定影响不大,且称样量0.12 g左右消耗高氯酸滴定液的体积约8mL更符合《中国药典》(2020年版)、《中国药品检验标准操作规范》(2019年版)对称样量的要求.
【机 构】
：
广西梧州制药(集团)股份有限公司,广西梧州543000
论文部分内容阅读
目的:通过不同的称样量对注射用氨甲环酸含量的影响,来验证所采用的分析方法的科学性、准确性和可行性.方法:取三批次注射用氨甲环酸产品,采用不同的称样量、不同的检验人员、液相所测得的含量结果等数据进行比对;通过重复性试验、中间精密度来进一步进行论证.结论:非水滴定法样品的称样量对于注射用氨甲环酸含量测定影响不大,且称样量0.12 g左右消耗高氯酸滴定液的体积约8mL更符合《中国药典》(2020年版)、《中国药品检验标准操作规范》(2019年版)对称样量的要求.
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