A Robust and Sensitive Instrument for Quantification of N-Nitroso-N-Des Methyl Diltiazem Impurity in Diltiazem Drug Product

[ BROCHURE ] SUPPORTING THE CHALLENGE OF NITROSAMINE DRUG SUBSTANCE RELATED IMPURITIES ANALYSIS N-Nitrosamines are potentially mutagenic impurities that may pose a risk of cancer to humans when exposed over a prolonged period. Since 2018, global regulatory bodies have required…

Xevo TQ-S Cronos [ INDIA DEMO LAB ] A Robust and Sensitive Instrument for Quantification of N-Nitroso labetalol impurity in Labetalol Drug Product. INTRODUCTION: A recently published general chapter in USP-NF, General Chapter <1469> Nitrosamine Impurities, identifies possible sources in…

Xevo TQ-S Cronos [ INDIA DEMO LAB ] A Robust and Sensitive Instrument for Quantification of N-Nitroso Nortriptyline Impurity in Amitriptyline Drug Product. INTRODUCTION: Recently, FDA has received additional reports of certain types of nitrosamine impurities that formed in several…

Application Note Quantitation of N-Nitroso-DesmethylDiltiazem, an NDSRI Impurity of Diltiazem Hydrochloride in Drug Product Using LCMS/MS Pavan Kukkadapua, Marian Twohigb, Padmakar Wagha a Waters Corporation, Bangalore, India b Waters Corporation, Milford, United States Published on August 19, 2026 Abstract Since…