Abstract
Author(s): Himanshu H. Butani*, Abhijeetsinh D. Solanki, Dushyantkumar B. Patel, R. Suryanarayana and Petla Y Naidu
Comprehensive studies, control strategies and management of elemental impurities (EIs) in pharmaceutical products are provided by ICH in its Quality Guidelines (ICH Q3D) considering Safety and Quality of drug product for human use. Replacement of historical ‘Heavy Metal Test’ by introducing more sophisticated analytical methodologies such as AAS, ICP-OES, ICP-MS etc. opened the doors for the quantitative determination of EIs with stringent limits. Performing EI estimation requires sound scientific knowledge and sensitive analytical techniques that can deliver accurate results of each toxic EI present in targeted products. Continuous monitoring of EIs in manufacturing of pharmaceutical products with GLP/GMP compliance in line with regulatory guidelines helps to generate scientific-based risk assessments for over all possibilities for the presence of EIs from different sources (i.e. Drug Substance, Excipients, Solvents, Regents and Chemicals etc). For testing ICH Class 1, Class 2A, Class 2B and Class 3 EIs in single analytical method required samples prepared using microwave digestion technique. Developed methods were validated in-house as per ICH and USP <233>.
