The Mass Spectrometry society of Japan - The 71st Annual Conference on Mass Spectrometry, Japan
Japanese

Abstract

Table of contents

Timetable

Plenary Lecture

Symposium Sessions (Day1, Day2, Day3)

Basic Sessions (Day1, Day2, Day3)

Young Researchers' Sessions (Day1, Day2, Day3)

Poster Presentations (Day1, Day2, Day3)

Special Evening Sessions

Corporate Program

Poster Presentations

Day 2, May 16（Tue.）　　Room P (Foyer, Room 1004-1007)

2P-49　　PDF

Quantification of Nitrosamines in Metformin Using an Improved Tandem Quadrupole Mass Spectrometer

(1Nihon Waters, 2Waters)
oMotoji Oshikata1, Margaret Maziarz2, Paul Rainville2, Amy Bartlett2

Nitrosamine impurities are considered probable human carcinogens or compounds that can cause cancer.1,2 Since 2018, the discovery of nitrosamines in several marketed medicines resulted in disruptive product recalls. 3,4 Liquid chromatography-mass spectrometry (LC-MS) instrumentation have successfully been employed for the accurate identification and quantification of low-level nitrosamines in various pharmaceutical products.5,6 The development and performance of an UPLC™ method with tandem quadrupole mass spectrometer for the detection and quantification of nine nitrosamine impurities (NDMA, NDEA, NEIPA, NMOR, NDIPA, NDPA, NMPA, NMBA, NDBA) in metformin drug substance. The method demonstrated excellent quantitative performance reaching LOQ limits of 0.01 to 0.1 ng/mL in neat solvent and 0.025 to 0.1 ng/mL in 20 mg/mL metformin drug substance, respectively. The accuracy of nitrosamines in metformin drug substance resulted in recovery of 85 to 110%, respectively. The described UPLC-MS/MS method offers highly sensitive, specific, and accurate analysis of nitrosamines in metformin drug substance, enabling fit-for-purpose accurate monitoring of nitrosamines at residual levels that are critical product quality and safety. The system has the performance to meet regulations that are becoming stricter day by day.