Metals Testing

Explore the full range of atomic spectrometric techniques

Catalent is an industry leader in the determination of inorganic elements designed to support every stage of the product development lifecycle of pharmaceutical, biopharmaceutical, combination products and dietary supplements. Our industry proven workflows focus on quality above all else and our services include:

  • Assessment of sample preparation based on product formulation
  • Routine application of internal standardization
  • Accuracy, precision and robustness evaluation during development
  • Validation based on development phase and regulatory requirements

We specialize in the full range of atomic spectrometric techniques, each supported with redundant instrumentation:

  • Inductively Coupled Plasma Mass Spectrometry
  • Inductively Coupled Plasma Atomic Emission Spectrometry
  • Flame Atomic Absorption Spectroscopy
  • Graphite Furnace Atomic Absorption Spectroscopy
  • Cold Vapor Atomic Absorption Spectrometry for Mercury
Catalent Benefits

Catalent experts have core expertise in:

  • USP <232> Elemental Impurities – Limits and USP <233> Elemental Impurities  - Procedures
  • Inorganic Trace Analysis
  • Method Development and Method Validation
  • Metal Screening by ICP-MS or ICP-AES
  • Assay and Impurity Evaluation of Dietary Supplements
  • Container Closure Systems Characterization for Elemental Impurities
  • Extractables Testing for Elemental Impurities
  • Leachables Testing for Elemental Impurities
  • Stability and Release Testing
  • GMP/GLP Analyses
Catalent Capabilities

Unparalleled Service Capabilities:

  • Protocol Design per ICH Q3D
  • Protocol Design per USP General Chapter <233>
  • Protocol design per PQRI
  • Multiple sample preparation options including closed vessel microwave, hot block, and bomb digestions
  • Investigative screening analysis by ICP-MS and ICP-AES
  • Analysis of organic sample preparations
  • Regulatory consulting