Laboratory Practicum for Chapter <467> Residual Solvents

Course Description

USP, in partnership with Phenomenex, a worldwide manufacturer of separation science consumables, will present a comprehensive course including lectures and complementary laboratory sessions on use of the analytical procedure in General Chapter <467> Residual Solvents and using alternative testing protocols.

Implementation of the new USP requirements on testing for residual solvents in drug substances, products, and excipients becomes effective on July 1, 2008. Designed to harmonize with the International Conference for Harmonization (ICH), USP General Chapter <467> significantly increases the number of solvents for which a company must screen.

This course provides hands-on training to help you understand the revised methodology, learn to work with challenging compounds and/or matrices, and how to use properly validated methodologies. You can also take advantage of individualized attention of USP and Phenomenex experts who can answer your specific questions related to your issues surrounding Chapter <467>.

Who Should Participate

Lab managers, bench chemists, QA/QC personnel, those involved with method validation in the pharmaceutical and allied industries.

Duration

1 day

Agenda

Time	Description
8:30 - 9:30	Revised Chapter <467> Residual Solvent Testing
9:30 - 10:00	Practical Approach to the Implementation of Chapter <467> Part 1
10:00 - 12:00	Lab 1: Using the Analytical Procedure in Chapter <467> & the Option Method
12:00 - 1:00	Lunch (Provided)
1:00 - 2:30	Practical Approach to the Implementation of Chapter <467> Part 2
2:30 - 4:30	Lab 2: Problem Samples: Using Alternative Testing Protocols
4:30 - 5:00	Final Questions & Course Wrap Up

Contact Information

USP customer service, 1–800–227–8772 or

For additional information on Phenomenex, visit www.phenomenex.com.