ARE YOU READY FOR THE REPLACEMENT OF USP <231> HEAVY METALS?
Alcami Wants You to Stay in Compliance.
The U.S. Pharmacopeia (USP) retired the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> with an instrument-based approach on January 1, 2018. Though the existing wet chemistry methods have been in effect for nearly 100 years, the methods are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredient.
The USP heavily supports Inductively Coupled Plasma Mass Spectrometry (ICP-MS) as the replacement technique to screen and/or accurately quantitate the presence of any metals of interest. USP General Chapters <232> and <233> Elemental Impurities Limits and Procedures is the expected norm for evaluation and are already accessible monographs for analysis.
- Improve testing accuracy and speed
- Initial elemental impurity assessment
- Risk assessment on current material
- Validated method for testing at release
- Risk assessment report for filing
- Standalone elemental impurity method
- Limit test
- Full quantitation analysis
- Extractables, leachables, and samples with unknown metal impurities
Elemental Impurities - Everything You Need to Know
Are you ready for this regulatory change?
The methods outlined in USP General Chapter <231> will be retired on January 1, 2018. Though the existing wet chemistry methods have been in effect for nearly 100 years, the methods are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredient.
This webinar addresses:
- An overview of the updated requirement
- How and when this change will go into effect, and how it will affect you
- Strategies to help you stay in compliance
Elemental Impurities - A Deep Dive into Potential Contamination Sources
This webinar discusses an often overlooked scenario when testing for elemental impurities: the possible contamination from everyday pharmaceutical machinery. It’s important to understand and implement policies that can assist in a successful right-first-time risk assessment that accurately reflects your process.
This webinar will address:
- What has changed since our last webinar, Elemental Impurities- Everything you Need to Know
- The change to USP <232>, effective August 1, 2017
- An overview of the upcoming regulatory change and what it means for you
- Possible contamination sources that could affect the results of your elemental impurities analysis
- Elemental impurity evaluation on container closure systems (USP <661>) and packaging components (USP <670>)
Elemental Impurities Q&A - Ask Our Experts
With less than three months until the methods outlined in USP General Chapter <231> are retired, there is still much to discuss.
This webinar will feature an extended Q&A with our panel of experts to answer any questions you have regarding what lies ahead.
We will kick things off with:
- A brief overview of the updated requirement
- An explanation on extractables and leachables
- Regulatory filing information
Alcami has the best ICP-MS Elemental Impurity Solutions to keep you in compliance with changing compendial requirements.