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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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