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, and Cold Vapor AA.

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.

Help transitioning from USP <231>

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.

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