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Introduction to Photostability
A Practical Introduction to
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Practical HPLC in Pharmaceutical Analysis
| Type | Course |
|---|---|
| Language | English |
| Date |
August 17, 2009 from 08:30 am to 05:00 pm |
| Venue |
Crowne Plaza Hotel - The Hamilton 1001 14th St NW Washington, DC 20005 US |
| Chemistry Specialties |
|
| Chemistry Techniques |
|
| Contact |
American Chemical Society 1155 Sixteenth Street, NW Washington, DC 20036 US (800) 227-5558 shortcourses@acs.org |
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Analytical procedures are used to assure that the drug product meets applicable standards of identity, strength, quality, and purity during its expiration dating. The majority of analytical methods used in pharmaceutical development are HPLC analyses. cGMPs require stability indicating methods to monitor the drug product’s stability profiles. Therefore, method development and validation significantly impact the drug development process. Additional expectations are also placed on the monitoring of impurities and degradation products. This course focuses on reversed-phase analysis of drug substances and drug products (small molecule). It will discuss forced degradation strategies to develop stability-indicating analytical procedures. A review of ICH guidelines on validation and impurities will be done to help Pharmaceutical Manufacturers to gain better understanding of method validation by phases of drug development and regulatory expectations through a review of warning letters.