Solutions for Pharmaceutical Impurities

Introduction

With an ever-increasing consumption of pharmaceutical products by the world population, there are considerable concerns about the unknowns and impurities which are ingested along with these medicinal drugs. The nature of these impurities and their consequent effect may pose a potential hazard to human health. This makes identification, estimation, quantification and control of these impurities matter of great concern and challenge. Regulatory agencies are laying increasingly defined guidelines for different types of impurities both for drug substances and drug products. Chemical properties of these impurities is diverse. Accordingly, laboratories need to use variety of analytical equipment like LC-MS/MS, UHPLC, GC-MS, GC-MS/MS, ICP-MS. Shimadzu has been a trusted scientific partner for these analytical equipment, with workflows suitable for impurity analysis and compliance platforms tailor-made for pharmaceutical business environment. In this handbook, we share a variety of methodologies for different classes of impurities like elemental, organic, residual solvent and more. Methods described are in synchronization with relevant ICH guidelines and create a sound platform for scientists to initiate their quest for answers with confidence.

April 8, 2019 GMT