Detection of Genotoxic Impurities in API During Pharmaceutical Development, Revin Labs Private Limited

Introduction

A talk from the PerkinElmer Chemicals Summit – Pharmaceutical Chemicals Symposium

Revin Labs Private Limited (RLPL) is a provider of high-quality analytical testing services to the pharmaceuticals, chemicals, polymers, food and environmental industries. Revin is Drug Control Administration (DCA) approved and NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratory with strong analytical experience in Environmental, Microbiological, Analytical, Method development, and validation studies.

Dr. Nagarjuna P Reddy, Managing Director of Revin Labs reviews various sources of genotoxic impurities (GTI) and the techniques to characterize and identify them. NDMA, an N-nitrosamine pharmaceutical Class 1 impurity, has been identified as a probable human carcinogen, is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables and has the potential to affect the quality, safety and efficacy pharmaceutical products. The source of nitrosamine impurities in active pharmaceutical ingredients (API) varies, and the impurity can be introduced under a variety of stages in the API manufacturing process. It is essential to identify these impurities and limit them below the regulatory guidelines in the finished drug products. This presentation will review topics such as the impurities and their regulatory guidelines, hazard assessment approaches, and utilizing the PerkinElmer QSight LC/MS/MS for low detection if Nitrosamine.