Comprehensive Materials Testing and Analytical Services at Materials Metric

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Pharmaceutical Materials Testing & USP Extractables/Leachables Analysis

Pharmaceutical Materials & Drug Delivery Characterization

Pharmaceutical systems depend on precise material composition, chemical stability, and compatibility between drug products and delivery components. Extractable compounds, elemental impurities, and polymer degradation can affect product efficacy and patient safety.

Materials testing supports formulation development, packaging validation, and regulatory documentation aligned with USP and ICH expectations.

Materials Metric provides independent analytical characterization to support pharmaceutical developers and combination product manufacturers.

Industry Risks & Technical Challenges

Material interactions within pharmaceutical systems present significant regulatory and performance challenges.

Common challenges include:

  • Extractable compounds migrating into formulations
  • Elemental impurities exceeding ICH thresholds
  • Polymer degradation affecting release kinetics
  • Glass-container interaction issues
  • Elastomeric closure compatibility concerns

Undetected chemical risks can delay regulatory approval and compromise product safety.

Pharmaceutical Contract Manufacturing Quality Testing
Pharmaceutical Drug Delivery Testing Services

Our Analytical Approach to Energy Materials Testing

Our approach emphasizes comprehensive chemical characterization and stability evaluation aligned with regulatory guidance.

Our services include:

  • USP <1663> Extractables Testing
  • USP <1664> Leachables Analysis
  • ICP-OES / ICP-MS Elemental Impurity Testing (ICH Q3D aligned)
  • Thermal Stability Evaluation (DSC, TGA)
  • Polymer Compatibility and Degradation Studies
  • Glass Composition Verification

Independent testing supports regulatory submissions and internal risk assessments.

Applicable Standards & Regulatory Frameworks

Testing may reference:

  • USP <1663> – Extractables
  • USP <1664> – Leachables
  • ICH Q3D – Elemental Impurities
  • ISO 10993 (for combination products)

Our analytical data supports NDA, ANDA, and combination product submissions.

Medical Pharmaceutical Testing and Analysis Services

Materials We Evaluate

Pharmaceutical systems incorporate polymeric, inorganic, and packaging materials that must maintain chemical integrity.

Common materials include:

• PLGA and PEG polymers
• Lipid-based carriers
• Nanoparticles and microparticles
• Borosilicate pharmaceutical glass
• Elastomeric closures
• Coating systems

Common Failure Investigations We Support

Typical investigations include:

  • Unexpected extractable compound identification
  • Elemental impurity exceedances
  • Polymer instability under storage
  • Glass delamination concerns

Root cause identification strengthens regulatory readiness and quality control.

Why Independent Materials Testing Matters

Independent pharmaceutical materials testing reduces regulatory risk and supports defensible chemical characterization documentation.

Materials Metric provides objective analytical data aligned with regulatory expectations.

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To learn more about our services and capabilities, please contact us or submit the form below to discuss your project requirements.


Frequently Asked Questions

What materials testing does the pharmaceutical and drug delivery sector need?
Pharmaceuticals and drug delivery need extractables and leachables studies, container-closure and packaging characterization, particulate identification, and polymer and elastomer analysis. Testing confirms material compatibility with drug products and patient safety. Foreign-matter and contamination analysis support deviation and complaint investigations.
Which standards and regulations apply in pharmaceuticals and drug delivery?
Applicable USP chapters, ICH guidelines, and FDA regulatory expectations govern extractables, leachables, and container-closure testing. Materials Metric designs studies to align with the standards relevant to your product and submission. We cite a specific standard only when it genuinely applies.
What common failures or problems does testing address in pharmaceuticals?
Testing addresses leaching of chemicals from packaging and delivery devices, visible and subvisible particulates, foreign contamination, polymer degradation, and container-closure integrity concerns. It also identifies the source of unknown matter in products. Root-cause analysis supports CAPA and regulatory response.
Which techniques does Materials Metric use for pharmaceutical testing?
Materials Metric uses GC-MS and LC-MS for extractables and leachables, FTIR and Raman for polymer and particulate identification, and SEM-EDS and ICP-MS for inorganic particulates and trace metals. DSC and TGA characterize elastomers and plastics used in packaging and devices.
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