Quick Analysis of N-nitrosodimethylamine (NDMA) in Ranitidine Drug Substance and Drug Product by HPLC/UV

[ TECHNOLOGY BRIEF ] Reliable HPLC/UV Quantification of Nitrosamine Impurities in Valsartan and Ranitidine Drug Substances Margaret Maziarz and Paul Rainville Waters Corporation, Milford, MA, USA The ACQUITY Arc System with PDA Detector, integrated with an ACQUITY QDa Mass Detector…

ISOLATION OF A DEGRADATION PRODUCT OF RANITIDINE HYDROCHLORIDE USING THE WATERS ANALYTICAL SCALE PURIFICATION SYSTEM Authors: Margaret Maziarz, Ronan P. Cleary, Darcy Shave, Stephanie N. Harden, Paul D. Rainville, Jinxia Xia Affiliations: Waters Corporation, 34 Maple Street, Milford MA 01757…

[ TECHNOLOGY BRIEF ] Use of a Proprietary Polar Column Chemistry for the Separation of Nitrosamines in Sartan and Ranitidine Drug Substances Margaret Maziarz, Sherri Naughton, and Paul Rainville Waters Corporation, Milford, MA, USA The XSelect HSS T3 Column enables…

[ APPLICATION NOTEBOOK ] IMPURITIES Developing Safe and Effective Drugs INT RODUCTION NAVIGATION T he pharmaceutical industry is integral in maintaining public health by providing therapeutic and preventative medicines. T he cornerstones of bringing new medicines to market are quality,…