The new guidelines set by the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) have pushed the pharmaceutical and nutraceutical industries to provide accurate, quantifiable results for metal analysis in drugs, pharmaceutical substances and raw materials
USP outlines new limits in pharmaceutical products for arsenic, cadmium, lead, and mercury. The procedures focus on the use of ICP-MS for the analysis of low level impurities. ICP-MS instrumentation, along with accurate ICP-MS standards, allows for increased efficiency and accuracy of the analysis necessary to comply with the new regulations. In addition to the changes enacted by the USP.
Developed in accordance with USP Elemental Impurities, our range of products offers these additions to our Consumer Safety Compliance Standards line. These standards can be used as a calibration or check standard to verify Oral Daily Dose PDE, Parenteral Component Limit or Parenteral Daily Dose PDE as well as Inhalation Component Limit or Daily Dose. Our extensive experience in creating quality trace metal standards, coupled with our ICP-MS analysis, will ensure your company will remain compliant with the new and changing regulations.
Inorganic Ventures is staying on top of the revisions being made in regards to USP . With these continuous revisions over the years, you may require a newer method or an older method. We have added six of the most requested products to our stock catalogue. However, customs are our speciality, so if you don’t see a product that is exactly what you need, contact us for a custom quote.
Find a listing of our USP products below or download our sales flyer.
For additional information, please refer to our paper on USP 232 and ICH Q3D.