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Elemental impurities by ICPMS

ICP-MS Elemental Impurities Testing
Trace Metal Analysis per USP <232>/<233> & EP 2.4.20​​

Overview Service

Capzer Pharmaceuticals provides full-service GMP ICP-MS testing for elemental impurities in raw materials, APIs, excipients, in-process formulations, and finished products. Our FDA/DEA-registered lab meets USP <232>/<233>, EP 5.20/2.4.20, and ICH Q3D requirements for Class 1-3 metals and PDE compliance.​​

Our Approach

Samples undergo microwave digestion for complete digestion, followed by ICP-MS analysis with internal standards and matrix-matched calibration. We screen 24+ elements (Pb, As, Cd, Hg, Cr, Ni, etc.) at ppb levels, providing quantitative results, full data packages, and control recommendations.​​

Key Capabilities

  • USP Class 1 (Pb, As, Cd, Hg), Class 2A/B metals, and catalysts (Rh, Pd, Ir, etc.).
  • Dedicated inorganic lab space with microwave digestors and low-level IC for anions.
  • Custom method development/validation for complex matrices.​​

Benefits for Partners

Partners ensure regulatory compliance for ANDA/NDA filings with rapid, accurate trace analysis from our cGMP facility. This supports vendor qualification, stability studies, and risk-based control strategies for U.S. generics manufacturing.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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