USP’s colleague Kosuri et al. published this week, “GC-MS/MS method for trace level quantification of six nitrosamines impurities (NDMA, NDEA, NEIPA, NDIPA, NDPA, and NDBA) in commercially used organic solvents: Dichloromethane, Ethyl acetate, Toluene, and o-Xylene” in the Journal of Pharmaceutical Sciences.
The quantification of nitrosamines in commercial-grade solvents ranged from 100 ppb to 8000 ppb with respect to the sample concentration of 25 mg/mL with good sensitivity in LOQ level. The quantification ranged from 5 ppb (for NDMA, NDEA, NEIPA, NDIPA, NDPA) and 13 ppb (NDBA) to 2000 ppb with respect to the sample concentration of 100 mg/mL for analytical grade solvents with good sensitivity in the proposed method.
Open Access: https://jpharmsci.org/article/S0022-3549(22)00536-6/fulltext