Lin Shao Hui Author
Subjects of specialization
Affiliation
Functionality-related characteristics (FRC); Hydroxypropyl methylcellulose (HPMC); Apparent viscosity; Degree of substitution for Hydroxypropyl content; Dissolution testing
Department of Formulation Development, Beijing Sciecure Pharmaceuticals Co., Ltd., Beijing, China 101301
| Lin Shao Hui Department of Formulation Development, Beijing Sciecure Pharmaceuticals Co., Ltd., Beijing, China 101301 |
Research Article Open Access
Author(s): Himankar Baishya, Zhou Yangxing, Wangshengmin and Lin Shao Hui
A selective and sensitive liquid chromatography–mass spectrometry (AB SCIEX QTRAP 5500) method was developed for quantitative determination of genotoxic impurity, hexyl chloroformate, in drug substance. The method was developed by derivatizing the hexyl chloroformate (HCF) to complex compound hexyl benzylcarbamate (HBC) by reaction with benzylamine. This method provided good sensitivity for quantification of hexyl chloroformate at a concentration of 10 ppm in 10 mg/mL DEM sample solution. The compounds were chromatographed under isocratic condition on poroshell EC-C18 (2.7 μm particle packed in 4.6 x 50 mm column) column with mobile phase of 0.1% v/v ammonium hydroxide in water (pH adjusted to 6 using acetic acid) and acetonitrile in ratio of 1:1 v/... view more»