Pharma Focus Asia

Proposed new ICH and USP methods for elemental impurities: The application of ICP-MS and ICP-OES for pharmaceutical analysis

The United States Pharmacopeial Convention (USP), in parallel with the International Conference on Harmonisation (ICH), is developing new methods for inorganic impurities in pharmaceuticals and their ingredients. The current USP method, <231> “heavy metals limit test”, is acknowledged to be inadequate and is due to be replaced with new General Chapters USP<232> (Limits) and <233> (Procedures) in December 2015. The new methods will address the limitations of the current method, extending the list of analytes, reducing maximum permitted exposure limits and taking account of the route of exposure. The new methods will also introduce the use of closed vessel sample digestion and modern instrumental techniques to ensure the accurate recovery and determination of individual analyte concentrations. This White Paper discusses the development of the new USP General Chapters and the ICH Guideline for Elemental Impurities (Q3D) and how Agilent’s 7900 ICP-MS and 5100 ICP-OES address the requirements of the proposed new methods.

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