By
Satinder Ahuja, Ahuja Consulting, Calabash, NC, USA
Karen Alsante, Pfizer Global R&D, Connecticut, USA
Description
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.
Included in series
Separation Science and Technology
Audience:
Pharmaceutical research institutes, Pharmaceutical industry, Pharmacy schools
