A Robust and Sensitive Instrument for Quantification of N-Nitroso Propranolol Impurity in Propranolol Hydrochloride 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 Nortriptyline Impurity in Amitriptyline Drug Product. INTRODUCTION: Recently, FDA has received additional reports of certain types of nitrosamine impurities that formed in several…

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 Argatroban impurity at 0.3 ppm in Argatroban Drug Product. INTRODUCTION: Recently, FDA has received additional reports of certain types of nitrosamine impurities that…