PerkinElmer
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Application Note

Determination of Nitrosamine Impurities in Active Pharmaceutical Ingredient (API) Using QSight 220 LC-MS/MS

Introduction

Nitrosamines are a well-known group of highly potent, mutagenic impurities formed by the reaction of secondary amines with nitrite under acidic conditions. The most probable nitrosamine impurities are NDMA, NDEA, NMBA, NDBA, NDIPA, NEIPA. Following the initial observance of nitrosamine impurities in sartan drugs used to treat high blood pressure and congestive heart failure in 2018, acceptable daily intake levels of 96 ng/day for NDMA and NMBA, and 26.5 ng/day for NDEA, NDBA, NDIPA and NEIPA have been adopted by most of the regulatory bodies.

This application note describes an efficient, sensitive and reproducible method developed using the PerkinElmer QSight 220® LC/MS/MS for the detection and quantification of NDMA, NDEA, NMBA, NDBA, NDIPA and NEIPA impurities in sartan and metformin active pharmaceutical ingredients (APIs).