|Recent USP changes: - Regulatory and Quality Aspects of Sample Preparation|
|Event Date: September 18, 2012 at 11:00 AM EDT|
The United States Pharmacopeia (USP) has recently made revisions which will have a positive impact on the quality of current analytical sample preparation methods.
An update to Chapter <841> Specific Gravity was published in the March/April 2012 Pharmacopeial Forum 38(2) which states that the use of mass for preparation of solutions is allowed, providing the density is known. This change supports gravimetric addition of the diluent without a need to revalidate the method. USP is due to post this revision in USP 36-NF 31 Supplement 1 in early 2013.
In addition, USP is proposing an update to Chapter <1251> Weighing on an Analytical Balance. The revision, expected to be published in the September/October 2012 Pharmacopeial Forum and then in USP 36-NF 31 Supplement 2 in 2013 will offer a detailed description of the steps involved in gravimetric dosing for sample and standard preparation.
This educational webinar will explain these USP updates in more detail and demonstrate how the changes will give the industry the opportunity to significantly improve the sample preparation process. The key benefits of a gravimetric approach, including improved accuracy and precision of results, enhanced data tracking and security and minimized substance and solvent consumption, will be addressed.
Key Learning Objectives:
- Understand how changes to the US Pharmacopeia will have a positive impact on your current sample preparation process
- Find out why FDA and USP would support gravimetric sample preparation methods
- Learn how to incorporate gravimetric methods into an existing workflow to improve quality of results and minimize substance consumption in the laboratory
Gregory P. Martin
President of Complectors Consulting, Chair of the USP Expert Panel on Weights & Balances, and Former Director of Pharmaceutical Analytical Chemistry at Merck Research Laboratories
Joanne Ratcliff, PhD
Communication Project Manager, Laboratory Weighing
Mettler Toledo AG
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