Elemental Impurities Analysis Services

Drug substance/ products may contain trace amounts of elemental impurities that could be harmful, even at low concentrations. We test heavy metal or elemental impurity residues to ensure compliance with current regulatory requirements. Energon Labs offers highly sensitive ICP-MS testing services in line with ICH Q3D Guideline for Elemental Impurities. We test a variety of sample types and matrices for trace elements, including organic and inorganic materials, as well as aqueous and non-aqueous substances.

We conduct analyses of over 24 elements, both metallic and non-metallic, as listed in ICH/EP/USP, with permitted daily exposures (PDEs) ranging from low parts per trillion (ppt) to high parts per million (ppm). Our mass spectrometry instrument features a unique collision cell that removes polyatomic interferences, enabling the analysis of complex matrices. Additionally, our high matrix introduction (HMI) equipment supports direct analysis of samples with high levels of dissolved solids.