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Analysis of Five Nitrosamine Impurities in Drug Products and Drug Substances Using Agilent GC/MS/MS Instrumentation
This application note highlights a comprehensive solution for the determination
and estimation of five nitrosamine impurities (NDMA, NDEA, NEIPA, NDIPA, and
NDBA) in sartan drug products and drug substances at trace levels using an Agilent
7890B or 8890 GC coupled to an Agilent 7010B triple quadrupole GC/MS system.
The 7010B triple quadrupole GC/MS is equipped with a high-efficiency source (HES)
that offers excellent sensitivity, repeatability, and precision while outperforming
regulatory limits. The method allows for LOQs that are 2 to 20 times lower than what
is required by current regulations.
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