Handbook of Isolation and Characterization of Impurities in Pharmaceuticals is popular PDF and ePub book, written by Satinder Ahuja in 2003-07-18, it is a fantastic choice for those who relish reading online the Medical genre. Let's immerse ourselves in this engaging Medical book by exploring the summary and details provided below. Remember, Handbook of Isolation and Characterization of Impurities in Pharmaceuticals can be Read Online from any device for your convenience.
Handbook of Isolation and Characterization of Impurities in Pharmaceuticals Book PDF Summary
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.
Detail Book of Handbook of Isolation and Characterization of Impurities in Pharmaceuticals PDF
- Author : Satinder Ahuja
- Release : 18 July 2003
- Publisher : Academic Press
- ISBN : 012044982X
- Genre : Medical
- Total Page : 444 pages
- Language : English
- PDF File Size : 8,6 Mb
If you're still pondering over how to secure a PDF or EPUB version of the book Handbook of Isolation and Characterization of Impurities in Pharmaceuticals by Satinder Ahuja, don't worry! All you have to do is click the 'Get Book' buttons below to kick off your Download or Read Online journey. Just a friendly reminder: we don't upload or host the files ourselves.