Nitto Avecia Pharma Services | Elemental Impurity Analysis

Compliance with USP and ICH

In an effort to improve and modernize the USP General Chapter for Heavy Metals <231>, the USP harmonized with ICH and proposed the addition of two new General Chapters and a Supplemental General Chapter:

<233> Elemental Impurities – Procedure
<232> Elemental Impurities – Limits
<2232> Elemental Contaminants in Dietary Supplements

Our methods comply with the new chapters and provide better precision and accuracy than those that could be achieved with USP <231>.

Modern instrumentation

We have a full complement of instrumentation for elemental impurity analysis including ICP-MS, ICP-OES, Graphite AA, Flame AA, Cold Vapor AA, and microwave digestion.

Experience counts

We have experience analyzing a variety of sample types including raw materials, drug substances, drug products and excipients. We can assist clients in the pharmaceutical, nutraceutical, biopharmaceutical, and medical device industries.

Bridging the Gap from Heavy Metals Testing to Elemental Impurity Compliance

Do you have a product that hasn’t been transitioned to the new USP methods? Let us help you. We have already helped numerous clients transition away from USP <231> to keep them compliant.