氯氮䓬制剂及原料药中主要杂质的测定。
Determination of major impurity in chlordiazepoxide formulations and drug substance.
作者信息
French W N, Matsui F F, Smith S J
出版信息
J Pharm Sci. 1975 Sep;64(9):1545-7. doi: 10.1002/jps.2600640928.
PMID:1185576
Abstract
Procedures for quantitating the lactam impurity, 7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one 4-oxide, which can be present in chlordiazepoxide formulations, is presented. The method consists of trapping chlordiazepoxide in sulfuric acid in kieselguhr, eluting the impurity with ether, and quantitating by UV spectrophotometry in absolute alcohol at 312 nm.
摘要
介绍了可存在于氯氮卓制剂中的内酰胺杂质7-氯-1,3-二氢-5-苯基-2H-1,4-苯并二氮杂卓-2-酮4-氧化物的定量方法。该方法包括将氯氮卓捕集在硅藻土中的硫酸中，用乙醚洗脱杂质，并在312nm处用无水乙醇中的紫外分光光度法定量。
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