Trace Level Quantitation of 8 Nitrosamines Including Varenicline Nitroso-Drug Substance Related Impurity (VNDSRI) in Varenicline Tablets Using LCMS-8045

User Benefits

- A simple and robust LCMS method for the determination of eight Nitrosamines including VNDSRI in Varenicline tablets. - The LCMS-8045 easily achieves much lower LOQ than prescribed in USFDA-published testing method on VNDSRI.

Introduction

Varenicline is a prescription medication used to treat smoking addiction. It is a high-affinity partial agonist for the α4β2 nicotinic acetylcholine receptor subtype (nACh) and has the capacity to reduce the feelings of craving and withdrawal caused by smoking cessation. It is estimated that Varenicline successfully helps one of every eleven people to be abstinent from tobacco for six months. It is on the World Health Organization's List of Essential Medicines and is also available as a generic medication. USFDA has identified levels of Varenicline Nitroso-Drug Substance Related Impurity (VNDSRI) which is also known as N- nitroso-varenicline above USFDA’s acceptable intake limit in some samples of Varenicline finished drugs. To ensure the safety and quality of Varenicline drug substance and drug product, the USFDA has developed and validated a method to determine the presence or absence of VNDSRI.

June 11, 2023 GMT