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>. The method is inadequate in that it cannot distinguish among the different metals, does not give individual concentrations, and has very limited sensitivity.

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; some 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.)

ICP-MS Services

  • 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

Read More About ICP-MS Heavy Metal Analysis

Pacific BioLabs