Elemental Impurities F, 13,000 mg/kg in 5% HNO3, 125 mL

ICH Standards

The new guidelines set by the Internatioal 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 <232> outlines new limits in pharmaceutical products for arsenic, cadmium, lead, and mercury. The procedures forcus on the use of ICP-MS for the analysis of low level impurities. ICP-MS instrumentation, along with accurate ICP-MS standards, allow 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 <232> Elemental Impurities, SPEX CertiPrep offers hese 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 your ICP-MS analysis, will ensure your company will remain compliant with the new and changing regulations.