Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is the most sensitive technique available for multi-element trace metal analysis, capable of measuring most elements of the periodic table at concentrations in the parts-per-trillion (ppt) range in a single analytical run. The technique introduces a sample into a high-temperature argon plasma (approximately 8000-10000 K) that completely atomizes and ionizes the sample, and the resulting ions are sorted by mass-to-charge ratio in a quadrupole mass spectrometer.

ICP-MS has become the definitive technique for pharmaceutical elemental impurity testing per ICH Q3D, which requires determination of 24 elements (Class 1: As, Cd, Hg, Pb; Class 2A/2B: Co, V, Ni, Tl, Pt, etc.; Class 3: Ba, Cr, Cu, Li, Mo, etc.) in drug products. The simultaneous multi-element capability enables measurement of all 24 ICH Q3D elements in approximately 10 minutes per sample.

Beyond pharmaceuticals, Auriga uses ICP-MS for food heavy metals testing against FSSAI regulatory limits, water quality analysis for trace metals per IS 10500 and WHO guidelines, environmental monitoring for metal contamination, and nutraceutical testing for heavy metals per FSSAI Health Supplements Regulations.

Applications

ICH Q3D elemental impurity testing

Heavy metal analysis in pharmaceuticals

Trace element analysis in food

Water quality testing

Environmental monitoring

Key Capabilities at Auriga Research

  • Sub-ppb detection limits
  • Multi-element analysis in single run
  • ICH Q3D compliant methodology
  • Isotope ratio measurements

Testing Services Using ICP-MS

ICP-MS supports multiple Auriga testing verticals — the same instrumentation and expertise serving different regulatory requirements and industry sectors.

Frequently Asked Questions

What elements does ICP-MS measure for ICH Q3D compliance?
ICH Q3D requires control of 24 elemental impurities: Class 1 (highest toxicity): As, Cd, Hg, Pb. Class 2A (route-dependent): Co, V, Ni. Class 2B (higher permitted oral levels): Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt. Class 3 (lower toxicity): Ba, Cr, Cu, Li, Mo, Sb, Sn. Auriga ICP-MS measures all 24 elements simultaneously, with concentrations compared against oral, parenteral, or inhalation PDEs as appropriate for the dosage form.
How does ICP-MS achieve such low detection limits?
ICP-MS achieves ppt detection limits through: (1) The argon plasma at 8000-10000 K provides near-100% ionization efficiency for most elements. (2) Mass spectrometric ion counting provides inherently high sensitivity. Detection limits range from 1-10 ng/L for most elements. Collision reaction cell (CRC) technology removes polyatomic interferences that limit sensitivity for As, Se, and Fe.
What sample preparation is required for ICP-MS analysis?
Most solid and semisolid samples require acid digestion before ICP-MS analysis. Auriga uses microwave-assisted acid digestion (MAD) using concentrated HNO3 and HCl in Teflon vessels under elevated pressure and temperature. MAD provides complete digestion of pharmaceutical matrices, food products, biological tissues, and environmental solids while minimizing contamination risk. Liquid samples can often be analysed directly after dilution and acidification.
Why choose ICP-MS over AAS for pharmaceutical elemental testing?
For ICH Q3D-compliant testing, ICP-MS is preferred because: (1) All 24 required elements are measured in one run vs. sequential AAS. (2) ICP-MS achieves ppt detection limits needed for Class 1 elements at their low PDEs. (3) Isotope ratio measurements enable spike-recovery verification and isotope dilution quantification for improved accuracy.

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