Elemental Impurities (USP 232/233)
Work with Avomeen’s industry-leading expert scientists to identify impurities using advanced technology, ICP-MS coupled with various Digestion Techniques. Avomeen’s elemental impurity identification capabilities are driven by dedicated, trained, and experienced pharmaceutical scientists together with Ph.D. chemists who have decades of a combination of chemical analysis and regulatory expertise.
Contaminants, impurities, and residuals in pharmaceutical and biopharmaceutical products can inhibit progress to market when they fail to comply with such regulations as those set forth in The United States Pharmacopeia Convention (USP) 232 & 233 and The International Council for Harmonisation (ICH) Q3D.
Keeping Toxic Elements Away from Consumers
As of January 1, 2018, pharmaceutical manufacturers are now required to comply with new provisions outlined in USP 232/233, which call for biopharmaceutical manufacturers to ensure that their manufacturing processes are kept free from toxic metals.
With the unrivaled knowledge, advanced equipment and scientific expertise available at Avomeen’s laboratory, our scientists can perform qualitative screening and quantitative assays on everything from raw materials all the way to final product.
A Forward-Thinking Approach to Impurities
Our scientists specialize in element-specific protocols, method development, and validation. To ensure that your production process runs smoothly, it’s essential to put processes into place that prevent future complications with impurities.
Impurities can come from sources such as:
- Water used in the manufacturing process
- Residue left on equipment
- Containers or closures for products
- Active pharmaceutical ingredients (APIs)
- Excipients (inactive or other ingredients)
The team at Avomeen will help you develop quality control checks such as batch-to-batch testing, refined development methods, and analysis of supplies from raw material suppliers that will minimize elemental impurities in your product and production processes.
Implementing Risk Assessment
Ongoing risk assessment helps define and refine processes for controlling and preventing elemental impurities. The Avomeen team is experienced in the risk-based approach to compliance with elemental impurities regulations, and our expertise in both testing and consulting can help you maximize the effectiveness of your risk assessments.
The FDA also mandates that applications for new products are accompanied by a risk assessment summary for elemental impurities. To remain in compliance with the mandate, previously approved pharmaceutical products must also be submitted with documentation on changes in controls. Even if no changes take place, the FDA still encourages manufacturers to deliver an annual risk assessment summary.
It’s All about the Follow-Up
Avomeen works above the standard on every new project that comes through our doors. We are not just the analysts on elemental impurity identification projects; we are also the consultants.
Once impurity identification is complete, our team takes advantage of readily available scientific expertise to troubleshoot and refine manufacturing processes and techniques to provide a complete solution.
If you have a complex analytical problem that needs solving, please:
Use our quick quote form or contact us for more information.