Whitepapers/App Notes/Posters

Application note: Testing and validation of various antacids for class 1 and 2A elemental impurities

Posted: 18 April 2017 | | No comments yet

In this paper, PerkinElmer present data to illustrate the successful validation of the NexION® 2000 ICP Mass Spectrometer for the determination of Class 1 and 2A elemental impurities in antacids according to USP General Chapter <233>…

The United States Pharmacopeia (USP) has announced that its new standards for elemental impurities in drug products will be implemented on January 1, 2018. General Chapters <232> and <2232> specify the list of elements and their permissible daily exposure (PDE) limits based on the route of administration.

USP has now harmonized the list of elemental impurities, as well as their PDEs, with the International Conference on Harmonization (ICH) Q3D Step 4 document. In June 2016, the FDA issued guidance on elemental impurities covering ICH Q3D in drug products.

As the deadline for assessing and monitoring elemental impurities approaches, pharmaceutical manufacturers and their service laboratories need to act now or risk not being in compliance with the new regulations. Compliance requires that the analytical methodology be capable of accurately measuring low concentrations of elemental impurities in drug products or its components, as necessary, to ensure patient safety.



This application note is restricted - login or subscribe free to access

European Pharmaceutical Review Issue 4 2022Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.

Why subscribe? Join our growing community of thousands of industry professionals and gain access to:

  • bi-monthly issues in print and/or digital format
  • case studies, whitepapers, webinars and industry-leading content
  • breaking news and features
  • our extensive online archive of thousands of articles and years of past issues
  • ...And it's all free!

Click here to Subscribe today Login here