Trace metal impurities pose risks to human health as well as to the quality and efficacy of pharmaceutical products. Recent changes to regulatory guidelines require the specific quantitative analysis of pharmaceutical products using ICPOES or ICP-MS. USP <232> Elemental Impurities – Limits, USP <233> Elemental Impurities – Procedures, and Ph.Eur. Chapter 5.2 align with ICH Q3D.
We have developed a set of certified reference materials to perform each of the requirements for USP <232>/ICH Q3D compliance that are traceable directly to the National Institute of Standards and Technology (NIST) SRMs. Each of the standards that LGC produces for USP <232> and ICH Q3D compliance meets the stringent requirements of ISO 17034 and ships with a comprehensive Certificate of Analysis.
We offer a complete CRM kit for the entire range of target elements, including an internal standard optimised for this application. LGC Standards can also provide you with single element standards for your specific needs.