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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 |
April 9, 2008 from 08:30 am to 05:00 pm |
| Venue |
Doubletree New Orleans 300 Canal St New Orleans, LA 70130 US |
| Chemistry Specialties |
|
| Chemistry Techniques |
|
| Contact |
ACS 1155 Sixteenth Street, NW Washington, DC , 20036 US 1-800-227-5558 ext. 4508 202-872-6336 service@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. Registrants will receive a copy of Modern HPLC for Practicing Scientists, by Dong (Wiley-Interscience, 2006) with their registration.