Dawson B A, Lawrence R C
J Assoc Off Anal Chem. 1987 May-Jun;70(3):554-6.
A number of selected drug formulations on the Canadian market were analyzed for N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) content by using a gas chromatograph interfaced to a thermal energy analyzer (GC/TEA). Of the 34 formulations analyzed, NDMA was found in 21 at levels up to 12 ppb and NDEA was found in 11 at levels up to 0.6 ppb. In many cases, the drug entity in the formulation did not contain the precursors for the observed nitrosamines.
使用与热能分析仪联用的气相色谱仪(GC/TEA),对加拿大市场上一些选定的药物制剂进行了N-亚硝基二甲胺(NDMA)和N-亚硝基二乙胺(NDEA)含量分析。在所分析的34种制剂中,21种检测出含有NDMA,含量高达12 ppb;11种检测出含有NDEA,含量高达0.6 ppb。在许多情况下,制剂中的药物成分并不包含所观察到的亚硝胺的前体物质。