Executive Interview : Q&A with Dr.Saranjit Singh on Stability Testing, Impurity Profiling & Degradation Studies

Exclusive Interview on Drug Stability Testing, Impurity Profiling & Degradation Studies of Pharmaceuticals and ICH guidelines

Key points discussed on Stability Testing

> About stability testing of pharmaceuticals.
> Regulatory status of stability testing of drugs worldwide
> Procedure to be followed for stability testing
> Necessity of stability testing of all pharmaceuticals or some specific class of drugs only to be tested for stability
> Procedure for stability testing of biological
> Analytical method selection & development
> Stability testing conditions reuirements per country

Key points discussed on Impurity Profiling & Degradation Studies

> Concepts of impurity profiling & degradation chemistry,
> Impurity control is done in pharmaceuticals
> Current developments of drug degradation studies
> Challenges in setting impurity standards for API’s & dosage forms
> Technologies that are being used for impurity profiling
> Standards of impurities & degradation products
> Impurity standards for Indian pharma industry
> Dr.Singh role in rationalizing the impurity testing requirements as a member of Indian Pharmacopoeia Commission
> Dr.Singh achievements & contributions to pharmaceutical field.

Dr Saranjit Singh

Dr Saranjit Singh is Dean, and Professor & Head of the Department of Pharmaceutical Analysis at the National Institute of Pharmaceutical Education and Research (NIPER) at S.A.S. Nagar, Panjab, India. He is a member of Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations and also a temporary advisor to the World Health Organization. He is also a member of the Scientific Committee of the Indian Pharmacopoeia Commission. He is in education and research for the last 26 years. He has published ~140 research papers, general articles and book chapters. He has delivered ~270 invited lectures and has spoken at the fora of AAPS, USP, DIA, IPA, IDMA, etc. He is recipient of Professor M.L. Khorana Memorial Lecture Award from Indian Pharmaceutical Association; and Eminent and Outstanding Analyst Awards from Indian Drug Manufacturers Association. His research interests include stability testing and impurity/degradation/metabolite profiling.