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  • Extractables & Leachables
    • For Pharma
      • USP <661-665>
      • USP <1663-1664>
    • Advanced Chromatography
      • Triple Quadrupole LC-MS/MS
      • Polycyclic Aromatic Hydrocarbons (PAHs) Detection via GC-MS
      • Early Biologics Support
      • Nitrosamine Method Development
      • PFAS Testing Capabilities
      • Small Molecule Impurity and Assay Development
      • Comprehensive GC-MS and LC-MS Screening
      • Custom Method Development and Validation Across Multiple Platforms
    • Accelerated Aging Studies
    • Elemental Impurities
    • Method Development
    • Method Validation
  • CCIT
    • Leak Detection Technologies
      • Laser-Based Gas Headspace Analysis
      • High Voltage Leak Detection (HVLD)
      • Vacuum Decay Testing
    • Cryogenically-Stored Products
    • Deep-Cold and Ultra-Cold Stored Products
    • ICH Stability and Sample Storage
    • Residual Seal Force (RSF)
    • Shipping Studies
  • Particulate Analysis
    • USP 788 Particulate Matter in Injections
    • USP 790 Visible Particulates in Injections
    • Contamination Control and Source Determination Investigations
    • Difficult-to-Inspect Parenteral (DIP) Products
    • ID Testing for Visible Particle Defects and Foreign Particulate Matter
    • Release Testing for USP 787, 788, 789; EP 2.6.20; JP 6.07
    • Rinse Studies for Primary Containers, Closures, Ready-To-Use (RTU), and Single-Use Systems (SUS) Products
  • Glass Delamination
    • USP 1660 Glass Delamination Screening and Testing
      • Glass Inner Surface Analysis
      • Extracted Elements in Solution
      • Lamellae and Visible and Subvisible Glass Particles
    • Aggressive Screening Conditions Studies
    • Screening Strategy for Drug Products and Glass Vials
    • Early Predictive Screening Studies
  • Functional Testing
    • USP 382
    • Break Loose Glide Force
    • Container Closure Integrity Testing (CCIT)
    • Needle and Spike Access Functional Suitability Tests
    • Packaging & Delivery System Integrity Tests
    • Plunger Functional Suitability Tests
    • Residual Seal Force (RSF)
    • Tip Cap and Needle Shield Functional Suitability Tests
  • Medical Device Analysis
  • Early-Phase Development
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Analysis Solutions
Analysis Solutions
  • Home
  • Extractables & Leachables
    • For Pharma
      • USP <661-665>
      • USP <1663-1664>
    • Advanced Chromatography
      • Triple Quadrupole LC-MS/MS
      • Polycyclic Aromatic Hydrocarbons (PAHs) Detection via GC-MS
      • Early Biologics Support
      • Nitrosamine Method Development
      • PFAS Testing Capabilities
      • Small Molecule Impurity and Assay Development
      • Comprehensive GC-MS and LC-MS Screening
      • Custom Method Development and Validation Across Multiple Platforms
    • Accelerated Aging Studies
    • Elemental Impurities
    • Method Development
    • Method Validation
  • CCIT
    • Leak Detection Technologies
      • Laser-Based Gas Headspace Analysis
      • High Voltage Leak Detection (HVLD)
      • Vacuum Decay Testing
    • Cryogenically-Stored Products
    • Deep-Cold and Ultra-Cold Stored Products
    • ICH Stability and Sample Storage
    • Residual Seal Force (RSF)
    • Shipping Studies
  • Particulate Analysis
    • USP 788 Particulate Matter in Injections
    • USP 790 Visible Particulates in Injections
    • Contamination Control and Source Determination Investigations
    • Difficult-to-Inspect Parenteral (DIP) Products
    • ID Testing for Visible Particle Defects and Foreign Particulate Matter
    • Release Testing for USP 787, 788, 789; EP 2.6.20; JP 6.07
    • Rinse Studies for Primary Containers, Closures, Ready-To-Use (RTU), and Single-Use Systems (SUS) Products
  • Glass Delamination
    • USP 1660 Glass Delamination Screening and Testing
      • Glass Inner Surface Analysis
      • Extracted Elements in Solution
      • Lamellae and Visible and Subvisible Glass Particles
    • Aggressive Screening Conditions Studies
    • Screening Strategy for Drug Products and Glass Vials
    • Early Predictive Screening Studies
  • Functional Testing
    • USP 382
    • Break Loose Glide Force
    • Container Closure Integrity Testing (CCIT)
    • Needle and Spike Access Functional Suitability Tests
    • Packaging & Delivery System Integrity Tests
    • Plunger Functional Suitability Tests
    • Residual Seal Force (RSF)
    • Tip Cap and Needle Shield Functional Suitability Tests
  • Medical Device Analysis
  • Early-Phase Development
  • Resources
    • About Gateway Analytical
    • Accreditations & Certifications
    • Articles & Publications
    • Brochures
    • Career Opportunities
    • Case Studies & Webinars
    • Conferences & Events
    • News & Press Releases
    • ParticleID
    • Posters & Presentations
    • Contact An Expert
  • Industry Resources
  • About Gateway
  • Gateway Service Agreement
  • Early-Phase Development
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