Elemental Impurity Reference Materials

Trace metal impurities, originating from raw materials or production processes, pose risks to human health as well as to the quality and efficacy of pharmaceutical products. Regulatory guidelines require the specific quantitative analysis of pharmaceutical products using inductively coupled plasma techniques such as ICP-MS.

We have developed a set of ICH-USP certified elemental impurity reference materials, with stock concentrations for a wide range of analytes - configured to specific permissible daily exposure limits in order to greatly simplify your calculations in conforming to each requirement of USP <232> and ICH Q3D. Each of the standards that we produce for USP and ICH compliance meets the stringent requirements of ISO 17034, ships with a comprehensive Certificate of Analysis (CoA), and is traceable directly to the National Institute of Standards and Technology (NIST).

We also offer complete elemental impurity reference materials kits for the entire range of target elements, including an internal standard optimised for this application, as well as single-element standards for your specific needs.