May 15

ICH Q3D elemental impurities testing: are you prepared for the new ICH/USP regulatory guidelines?

LEnElementalImpuritiesAs a consequence of the new ICH/USP regulatory guidelines concerning testing of elemental impurities the way in which pharmaceutical companies and their suppliers will be required to test their APIs and excipients will change dramatically.

The guidelines, which aim to set out a global policy for limiting metal impurities in drug products and ingredients puts these impurities into various categories. In order to comply with the guidelines sponsors will need to carry out a detailed risk assessment of their materials in terms of these different categories.

USP <231> Heavy Metals test is being replaced with two new chapters, USP<232> Elemental Impurities (Limits) and USP<233> Elemental Impurities (Procedures). As a consequence the use of Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES) and Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS) will become the preferred standard approach for the determination of heavy metals in drug products, replacing the much out dated and non-specific / non quantitative wet chemical tests. With the added elemental specificity, accuracy and sensitivity (ppb / ppt range) afforded by ICP-OES / ICP-MS, sponsors will be able to confirm that their materials meet the new compliance criteria.

The new USP directive is scheduled for January 2018 and LGC is already prepared for what will be a very significant industry requirement. Sarah James, Principal Scientist within our CMC Analytical Services team will host a webinar on “Elemental Impurities: Multi-element analysis to ICH Q3D and USP<232><233>” on 27th May 2015. During the webinar Sarah will discuss the following:


  • Regulatory context of the guidelines
  • Describe the analytical challenges associated with this type of testing
  • Highlight the key essentials in delivering multi-element quantitative data.


Register for the webinar to learn more about the new ICH/USP regulatory guidelines.



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