Antellis, the elemental solutions !
You are a pharmaceutical company, a CMO/CDMO, a manufacturer of active pharmaceutical ingredients or excipients. You are faced to changes in elemental impurity regulations in drug products (ICH Q3D).
For API's, excipients, raw materials, durg products, for stability studies, for investigations or quality control, for supporting ICH Q3D risk analysis, we quantify elemental impurities. >
Heavy metal determination in cosmetic industry is becoming an important issue with the definition and the further application of new rules in a few months. >
In dietary supplements and nutraceuticals, industry rules impose low concentrations of heavy metals such as As, Cd, Pb and Hg. Furthermore antellis is able to control trace elements either added or naturally occuring. >
Antellis develops and validates ICP-MS methods for quantifying elements (metal based drugs, metallic nanoparticles, medical devices,…) for toxicokinetic studies, pharmacokinetic studies, ADME, biodistribution, transcutaneous passage studies. >
Antellis determines heavy metal concentrations in organic or mineral raw materials, solvents, finished or semi-finished products according to your specifications. We also help manufacturers in investigating incidents during industrial processes (presence of elemental impurities or particles). >