Boston Analytical has extensive experience in elemental impurities testing indicating if trace metals are present in your product. This analysis is important since high concentrations can cause pharmaceuticals and supplements to be toxic. With our modern equipment and years of expertise, we can help you be assured there is nothing in your process or materials that would compromise your products.
We can help you achieve mandatory FDA and ICH quality guidelines through analysis, including method validation of USP <232> and <233> to determine the elemental, and sometimes isotopic, composition of excipients, raw materials, drug products, and finished products. Elemental impurities in pharma can come from water used in process, containers, closures, process equipment, active pharmaceutical ingredients (APIs) and excipients.
Compendial testing of pharmaceutical products at Boston Analytical is done using the latest instruments that include the ICP-MS which combines a high-temperature sources with a mass spectrometer to help to detect the metals at low concentrations. Our expert analysts will help ensure you meet all regulations necessary for safe products and a controlled manufacturing process.
Elemental Impurities Services
- Elemental Impurities – Limits, USP <232>
- Elemental Impurities – Procedures, USP <233>