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, which was proposed in the September/October 2012 Pharmacopeial Forum and is due to be published 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.
In this webinar, Gregory P. Martin, a former Director of Pharmaceutical Analytical Chemistry at Merck Research Laboratories, who is also Chair of the USP expert panels on “Validation and Verficiation” and “Weights and Balances”, and Joanne Ratcliff, a weighing and sample preparation expert from Mettler Toledo, will explain how these USP updates 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:
- Develop an understanding of how changes to the US Pharmacopeia will have a positive impact on your current sample preparation process
- Discover why the US Food and Drug Administration (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
Who Should Attend:
- Pharmaceutical and regulatory managers and scientists
- Experts engaged in or responsible for the preparation of samples and standards for analytical methods, including method validation and development in Analytical R&D or Quality Assurance / Quality Control (QA/QC) laboratories