The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized.
Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.
This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.
It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.
- Provides valuable information on isolation and characterization of impurities.
- Gives a regulatory perspective on the subject.
- Describes various considerations involved in meeting regulatory requirements.
- Discusses various sources of impurities and degredation products.
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A Volume in the Separation Science and Technology SeriesAbout the Author:
Satinder Ahuja earned his Ph.D. in analytical chemistry from the University of the Sciences, Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years while simultaneously teaching and guiding research as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on quality issues relating to chemicals/pharmaceuticals and water. Dr. Ahuja has published numerous papers and more than eighteen books. Two of his latest books are entitled "Water Reclamation and Sustainability" (Elsevier) and Comprehensive "Water Quality and Purification" (Elsevier). Others include "Monitoring Water Quality: Pollution Assessment, Analysis, and Remediation" (Elsevier, 2013); "Novel Solutions to Water Pollution" (ACS Symposium Volume, 2013); "Handbook of Water Purity and Quality" (Elsevier, 2009); and "Arsenic Contamination of Water: Mechanism, Analysis, and Remediation" (Wiley, 2008). A member of the executive committee of Rivers of the World Foundation (ROW), Dr. Ahuja is an expert on improving water quality and has organized numerous global symposia on this topic (American Chemical Society, UNESCO, etc.) In 2013, he gave a lecture on the nexus of food, energy, and water and chaired a symposium on the subject for the American Chemical Society meeting in New Orleans.
Dr. Karen Mills Alsante is a Senior Research Investigator in the Analytical Research & Development Department at Pfizer Groton Central Research. She worked as a Development Scientist in Groton Quality Operations for 3 years before moving to her current position in the Analytical Research & Development department in 1997. Over the past five years, Karen has established a Degredation Technology Group with the mission of gaining a better understanding of the chemical and physical stability of Pfizer drug substances and drug products at an earlier stage of the drug development process.
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