Reliable HPLC/UV Quantification of Nitrosamine Impurities in Valsartan and Ranitidine Drug Substances

Library Number:
APNT135044546
Part Number:
720006775EN
Author(s):
Margaret Maziarz and Paul Rainville
Source:
Waters
Content Type:
Application Notes
Content Subtype:
Technical Notes
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This study demonstrates the reliable quantification of six nitrosamine impurities (NDMA, NDEA, NEIPA, NDIPA, NDBA, and NMBA) in valsartan and NDMA in ranitidine by UV detection, with the added benefit of mass confirmation by mass spectral data using an ACQUITY QDa Mass Detector.

 


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