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ICP-MS
 

ICP-MS HEAVY METALS AND TRACE ELEMENT TESTING

USP 232 and USP 233 Elemental Impurities

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 element detection: 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-MSTrace 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>
  • Trace Element Screening in Materials and Devices
  • Quantitation of Metal-containing Pharmaceuticals and Formulations

Available Equipment

 
 
 
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