CEM have been developing products and methods for heavy metals analysis and sample preparation since 1986. Ahead of the change from USP method <231> to USP methods <232>/<233> for the heavy metals analysis of pharmaceutical-based products on January 1st 2018, CEM are offering to put their expertise at your disposal to assist with the transition.
These changes may seem daunting at first sight but with CEM’s help all laboratories can make a safe passage into this new era of trace metals analysis. The assistance takes two forms. Firstly CEM have produced an ebook ‘Complete Sample Preparation Guide for Elemental Impurities’ which does exactly as the title says giving you the information you need to learn more about ICP-MS Systems, microwave digestion, standards and validation.
This primer is designed specifically to prepare you for implementing USP 232/233 and ICH Q3D in your laboratory. It covers the methodologies for preparing and analysing samples as well as informing you on the new permitted daily exposures. What is more it’s free to download now.
The second way CEM are helping researcher and technicians in the USA is via hands-on training sessions at different locations across the country. You’ll prepare and analyse your own samples and be able to attend lectures by regulatory and industry leaders.
Subjects covered include: USP 232/233 Overview, New Global Directives on Heavy Metals in Pharmaceuticals: An ACS Perspective, Elemental Testing of Pharmaceuticals: An FDA Perspective, The Importance of Clean, High Quality Reagents and Standards, Hassle-Free Sample Preparation Utilising Advances in Microwave Digestion, Elemental Analysis in Compliance with USP <233>, Regulatory Compliance, Compliance From a Laboratory Perspective and Hands-on Sample Preparation and Analysis in the Lab.
Numbers for these invaluable workshops are limited though so you are advised to sign up now. The cost is probably less than you think, because they are also being organised for free by CEM.
Don't wait, given the time you need for implementation and validation, the time to act is now and with CEM’s help it need not cost you anything to be fully informed.
To download the ebook please click here.
To read more about USP 232/233 and ICH Q3D on the CEM website, please click here.