Determination of major impurity in chlordiazepoxide formulations and drug substance.

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.