Navigating the Complexities of Impurities in Pharmaceuticals

The management of impurities is crucial throughout the product lifecycle, from initial development to manufacturing and distribution.

Article

Published: January 3, 2025

Neeta Ratanghayra, MPharm

speaking with

Yaman Abdin, PhD ,

Gary Martin, PhD

& Naiffer Romero

A white tablet held with tweezers seen through a magnifying glass

Credit: iStock

Pharmaceutical impurities pose a persistent challenge, with even trace contaminants potentially compromising product safety, delaying approvals or triggering costly recalls. Understanding the sources of these impurities is critical for ensuring drug quality and protecting patients.

This article explores how evolving regulatory frameworks, analytical advances and collaborative efforts shape impurity management. Learn how experts are tackling known threats like nitrosamines while preparing for emerging risks, and discover the tools and strategies driving a safer pharmaceutical landscape.

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Meet the Author

Neeta Ratanghayra, MPharm

Freelance Medical Writer

Neeta Ratanghayra is a freelance medical writer specializing in developing content for the pharma, biotech and healthcare industries. She has a Master’s degree in Pharmacy and has worked on a variety of medical writing deliverables for global pharma companies and healthcare organizations. Before delving into medical writing, Neeta worked in the clinical research industry, where she handled multiple clinical research projects intended for various regulatory submissions.

Interviewing

White letters "YA" on a navy background.

Yaman Abdin, PhD

Postdoctoral Researcher

Yaman Abdin is a postdoctoral researcher at the Institute for Bioorganic Chemistry, School of Pharmacy, Saarland University, Germany. His research focuses on the philosophical, social and psychological aspects of pharmacy, encompassing drug development, regulation and application. He leads the 'Pharmasophy' group at the Institute for Bioorganic Chemistry.

White letters "GM" on a navy background.

Gary Martin, PhD

Adjunct Professor

Gary Martin is an American chemist and expert in NMR spectroscopy and medicinal chemistry. Formerly with the Structure Elucidation Group at Merck, he is now an adjunct professor of Chemistry at both Seton Hall University and Stevens Institute of Technology. His research focuses on developing new NMR methods for characterizing the molecular structure of pharmaceutical impurities, degradants, drug metabolites and natural products. Martin has written a widely used monograph on 2D NMR methods and coedited two volumes on modern NMR applications in natural product structure elucidation. He has published over 325 papers, more than 45 invited reviews and chapters, and delivered over 500 seminars and lectures at national and international meetings.

White letters "NR" on a navy background.

Naiffer Romero

Principal Scientist

Naiffer Romero is a Principal Scientist at the U.S. Pharmacopeia (USP), where he leads scientific outreach and technical engagement on national health priorities in Latin America and the United States. With more than 20 years of experience in the pharmaceutical industry and an expert in nitrosamine impurities, he manages USP’s Nitrosamines Exchange online community and serves as USP representative on several international nitrosamines workstream committees.

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Navigating the Complexities of Impurities in Pharmaceuticals

The management of impurities is crucial throughout the product lifecycle, from initial development to manufacturing and distribution.