Category Archive: Elemental impurities

Aug 11

Space is the place…to experiment

Bugs in Space – ATCC® Microbes are Go! by Lauren Cracknell. Students taking part in the ISSET programme at King’s College, London, have designed and prepared ‘micro-gravity experiments’ using ATCC’s Microbes. The intrepid microbes were launched into space on-board the Falcon 9 rocket and rendezvoused with the International Space Station on 5 June. The aim of …

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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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Jul 01

Discover what inorganic mass spectrometry can do

Inorganic mass spectrometry has a wide range of potential applications, from reference material development to nanoparticle analysis or pharmaceutical testing, as will be showcased by LGC scientists at the 18th Biennial National Atomic Spectroscopy Symposium (BNASS) on 4 to 6 July 2016. BNASS is the biennial meeting of the RSC Atomic Spectroscopy Group and provides …

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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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