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:
Our methods comply with the new chapters and provide better precision and accuracy than those that could be achieved with USP <231>.
We have a full complement of instrumentation for elemental impurity analysis including ICP-MS, ICP-OES, Graphite AA, Flame AA, and Cold Vapor AA.
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.
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.
10 Vanderbilt Avenue
Irvine, CA 92618
Tel: (949)-951-4425
Fax: (949) 951-4909
6 Vanderbilt Avenue
Irvine, CA 92618
4 Chrysler
Irvine, CA 92618
