Category Archive: CMC analytical services

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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Dec 12

Foreign particulate matter in pharmaceuticals

There has been a recent rise in the number of pharmaceutical product recalls due to the presence of Foreign Particulate Matter (FPM), and its effect on product efficacy and safety. FPM is either inherent (from the product itself), intrinsic (from the production process), or extrinsic (contaminating particles from outside). There is a regulatory requirement for …

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Feb 18

Quantitation of low level impurities using LC-MS/MS in GMP analysis

Register for the LGC webinar on In vitro antimicrobial efficacy testing

LC-MS/MS has been the technique of choice for trace organic analysis in most areas of analytical chemistry for over a decade and is now slowly but steadily becoming so in GMP pharmaceutical analysis. LC-MS/MS offers unrivalled sensitivity and selectivity as well as speed of analysis. The technique is able to routinely quantify down to 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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