Simultaneous Analysis of 10 Nitrosamines in an Active Pharmaceutical Ingredient Using a Triple Quadrupole Mass Spectrometer

User Benefits

- Meet Japanese, U.S., and European risk assessment standards for contamination with nitrosamines. - Reliable quantitative analysis of nitrosamines in an active pharmaceutical ingredient.

Introduction

Nitrosamines can be highly genotoxic, and the nitrosamines NDMA and NDEA are classified as group 2A carcinogens (probably carcinogenic to humans) by the International Agency for Research on Cancer (IARC). ICH M7 provides guidance for the assessment and control of mutagenic impurities in drug products and describes N-nitroso compounds as high-potency carcinogens (cohort of concern) that must be controlled at or below compound-specific acceptable limits. Acceptable intake limits are also being established by regulatory agencies in various countries for an increasing number of nitrosamines, so there is a demand for analysis methods that can quantitate a larger number of nitrosamine compounds. This article presents a case example in which the LCMS-8060NX triple quadrupole mass spectrometer was used to perform a simultaneous analysis of ten components including nine nitrosamines regulated by the U.S. Food and Drug Association (FDA) and European Medicines Agency (EMA), and N-Nitrosodi- n-propylamine (NDPA) regulated by the European Pharmacopoeia (Ph. Eur.) Commission.

September 29, 2022 GMT