Heavy Metal Elemental Impurity Analysis, USP <232> & <233>
Historically, inorganic impurities in pharmaceutical, biological and nutraceutical formulations have been measured according to the colorimetric method outlined in USP <231>. This method relies on the precipitation of one or more of only 10 heavy metals, and compares this precipitate visually to a standard. The USP <231> method is limited in that it cannot distinguish between each metal and does not give individual concentrations.
To address these limitations, modern instrumentation like the ICP-MS has been recommended as a replacement to determine heavy metals concentrations, and the USP has created new monographs for heavy metals and trace metal analysis: USP <232> and USP <233>.
Pacific BioLabs offers ICP-MS for metals detection and elemental impurities screening; many elements in the periodic table can be detected and quantified to a level of 0.1 ng/L or parts per billion (ppb).
ICP-MS Trace Element Detection and Novel Uses
Non-metallic elements can also be detected by ICP-MS, and based on the product, Pacific BioLabs’ analytical team can help develop and validate a method to detect metals and other elements. PBL has analyzed pharmaceuticals, medical devices, and raw materials. Our analysts can work to determine the best methodology to characterize a product.
Additionally, because some drugs and biologics contain metals (calcium and iron as metal centers for protein formulations, and platinum and chromium as production catalysts), it is possible to use ICP-MS to quantify the amount of drug in a solution, formulation, or even to analyze biological fluids (such as PK by ICP-MS.)
- Elemental Impurities Detection Compliant with USP <232> and USP <233>
- Heavy Metal Analysis in Materials and Devices
- Quantitation of Metal-containing Pharmaceuticals and Formulations
Available ICP-MS Equipment
- Agilent Technologies 7700 Series ICP-MS
- Instrumentation Details