Analysis of piperazine drug formulations for N-nitrosamines.
A quantitative method is described for the measurement of N-mononitrosopiperazine (NPIP) and N,N'-dinitrosopiperazine (DNPIP) in drug formulations containing piperazine, using a gas chromatograph interfaced to a thermal energy analyzer (GC/TEA). The method has detection limits of 20 ppb for NPIP and 12 ppb for DNPIP. In a survey of 6 products available on the Canadian market, all contained NPIP at levels of 0.38-15.3 micrograms NPIP/g piperazine and none contained any detectable amount of DNPIP.
Dawson
B A
BA
Health and Welfare Canada, Bureau of Drug Research, Ottawa, Ontario.
Lawrence
R C
RC
D002849:Chromatography, Gas; D008401:Gas Chromatography-Mass Spectrometry; D007202:Indicators and Reagents; D009602:Nitrosamines / Q000032:analysis*; D010879:Piperazines / Q000032:analysis*; D013757:Tetraethylammonium Compounds / Q000032:analysis
D007202:Indicators and Reagents; D009602:Nitrosamines; D010879:Piperazines; D013757:Tetraethylammonium Compounds