USP/ICH Standards

Guidelines set by 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.

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, 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 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.

USP 232 Elemental Impurities Brochure
ICH Global Compliance Standards Brochure
Pharmaceutical Standards Brochure