Trace metal analysis

USP 232 233

Trace metal analysis - detecting the unknown

The testing of trace metals in drug products, drug substances, biologics, dietary supplements, and medical devices is critical for determining the toxicity of a material and predicting its interactions with other compounds. Exova is a recognised world-leader in trace metal analysis. Testing for elemental impurities by ICPOES and ICPMS, in compliance with USP <233>, EP (2.4.20), and ICH Q3D gives you reliable, independent data for both raw materials and finished products.

Pharma trace metal analysis

Our experts can give you the information you need on the presence of a full spectrum of trace and heavy metals, including lead, arsenic, mercury, cadmium, and chromium. We also have the capability to separate and quantitate inorganic mercury, arsenic, and selenium from their various organic species

Trace metals analysis by ICPMS is also an excellent way to determine residual catalysts, such as palladium and platinum, in process intermediates and final products. As an addition to trace metal analysis, we also offer full compendial API and excipient testing to the EP, BP, JP, and USP compendia.

Proven ICPMS experience

Our Exova Santa Fe Springs (Southern California) laboratory was the first commercial laboratory to offer ICPMS. We were also one of the first in the world to offer cGMP compliant ICP-OES and ICP-MS testing services and have established an enviable reputation in this field. Sharing this extensive experience in trace metals analysis by ICPMS with our other global pharmaceutical laboratories in Canada and Europe, you can be assured that your needs are in capable hands.

Our trace metals analysis by ICPMS include:

  • Low detection limits allows testing to trace levels (ppb and ppt)
  • Full metals screen for 68 elements in a single analysis
  • As, Pb, Cd, and Hg by USP <232> and <233>
  • Cr, Cu, Mo, Ni, Pd, Pt, V, Os, Rh, Ru, Ir by USP <232>, <233>, and EP (2.4.20), (5.20)
  • Speciation of selenium, arsenic, mercury and iron
  • Rare elements
  • Metal catalysts and elemental impurities by USP <233> and EP (2.4.20)
  • Arsenic and arsenic speciation in foods and dietary supplements
  • Lead and Cadmium in PVC
  • California Proposition 65 compliance testing
  • ROHS and REACH compliance testing
  • Tributyltin in water and sediments
  • Chromium by ICPMS
  • Hexavalent Chromium analysis
  • Lanthanides determination
  • State-of-the-art ICPMS instruments with collision cells to minimize interferences and false positives.
  • Eight ICPMS devices to meet your needs

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