Analysis of Genotoxins (NDMA and NDEA) in Sartan Drugs and Drug Products by GC-MS (TN-2080)

Abstract:

N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) are Class 2A carcinogens that have been found to be present as impurities in several different generic drug substances and drug products used to treat hypertension. Accurate identification and quantification of these impurities is essential to assure quality and safety of the drug substance and drug product. In this technical note we illustrate a headspace GC-MS application that allows for ppb detection limits (LOQ equal to 1.5 ppb for NDMA and 0.9 ppb for NDEA; and LOD equal to 0.4 ppb for NDMA and 0.3 ppb for NDEA).

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

GC

Brands:

Zebron

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