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.
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.
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.