Tag Archive: Elemental impurities

Apr 05

The new ICH Q3D Elemental Impurities Guideline – nothing to fear if you act now

The ICH Q3D Guideline on Elemental Impurities has been adopted by the European and US Pharmacopoeias, meaning that by the end of 2017 all new and existing products in Europe and the US will need to be assessed. Initially it was thought that every marketed product would require full testing for trace metals. However, the …

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May 15

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

As 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 …

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