BA Sciences has extensive experience performing elemental impurities testing. Elemental impurities can be toxic at low to moderate levels when present in drug products. These impurities can find their way into products from the manufacturing process. With our modern equipment and years of expertise, we can help you be assured that any elemental impurities present in your product are controlled at safe levels.
Safe levels of elemental impurities in pharmaceutical products are outlined in the ICH Guidance for Industry Q3D(R2) Elemental Impurities. Instructions are provided in this guidance to calculate dose-based thresholds for elemental impurities. Testing is then conducted following USP chapters <232> and <233>.
Compendial pharmaceutical impurity testing at BA Sciences is done using the latest instruments that include Inductively Coupled Plasma – Mass Spectrometry (ICP-MS), which combines a high-temperature plasma source with a mass spectrometer to detect the metals at low concentrations. Our expert elemental impurities testing services will help ensure you meet all regulations necessary for safe products and a controlled manufacturing process.