In December 2014, the EU implemented Guideline ICH Q3D on Metallic Impurities in Pharmaceuticals (Guideline for Elemental Impurities). Within the context of ICH Q3D, metallic impurities must be identified, classified and their risks assessed. Merely visual limit value tests are no longer sufficient for this purpose. In the field of heavy metal analysis, Labor LS has established ICP-MS analysis as an element-selective and quantitative instrumental "state of the art" method. With this technology we analyse:
- Raw materials, active ingredients, excipients
- Process water
- Catalysts used,
- Finished medicinal products, etc.
Our services range from qualitative ICP-MS screening (up to 24 elements), qualitative analysis of the content of the heavy metals present through to matrix-specific validation of the analytical methods.