The United States Pharmacopeia has specified new limits and procedures for elemental impurities and toxic contaminants in drug products and dietary supplements. The current heavy metals limit test, USP <231> is soon to be replaced by the more accurate and modern USP methods including <232>, <233> and <2232>.
All drug products and supplements which are manufactured to be sold in the US market will have to comply with these new procedures. It is essential to show that your products comply with these new requirements, specifically for impurities like Pb, As, Cd and Hg.
EuTech, in an effort to meet the demands of the changing market, is offering US methods <232>, <233> and <2232> in our state of the art cGMP facility. We analyze a range of products including APIs, excipients, drug products and dietary supplements.
One of the most critical steps in running samples using ICP-MS is the sample preparation procedure. EuTech’s scientists have perfected this process and have worked with the most difficult types of matrices. EuTech is equipped with microwave digestion which limits contamination and improves the efficiency of the testing.
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EuTech has been working with the Pharmaceutical, Nutraceutical, Cosmetic and Medical Device industries for over 20 years. Our expert scientists will help you navigate through this new requirement and help you to develop the best methods for your samples.
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