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 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.

Can’t find the standards you are looking for? Spex CertiPrep®can make custom standards to meet your exact needs. Contact us for more information at [email protected] or call us at 732-549-7144.

Chemicals sold by Cole-Parmer are not intended for and should not be (i) used for medical, surgical or other patient oriented applications, or (ii) combined with any food product or ingested in any form.

This multi-element standard contains 7 elements.

• Elemental Impurities E standard is a 125 mL bottle which contains 2,500 mg/kg (2,500 ppm) Manganese; 1,000 mg/kg (1,000 ppm) Copper; 250 mg/kg (250 ppm) Chromium, Nickel; and 100 mg/kg (100 ppm) Cobalt, Molybdenum, Vanadium.

Hazardous material shipping fees may apply.