Scope of Services

Pace Analytical Life Sciences is ISO/IEC 17025 accredited and offers cGMP-compliant analytical support for the following products:

  • Drug Substances, Excipients and Finished Product

  • Inhalation Dosage Forms

  • Transdermal Dosage Forms

  • Topical Dosage Forms

  • Oral Dosage Forms

  • Films, Tapes, Adhesives and Packaging

  • Combination Drug-Device Products

  • Medical Devices

Pace Analytical Life Sciences also provides custom testing by request and client-specified testing.

Analytical Chemistry

Raw Material and Finished Products

  • Compendial Testing-USP/NF, EP, BP and JP
  • Organic Volatile Impurities USP [467]
  • Residual Solvents
  • Assay
  • Impurity
  • Dissolution
  • Particle Size Determination
  • Extractables and Leachables
  • Physico-Chemical:
    • Elastomeric Closures USP [381]
    • Plastics Aqueous and Non-Aqueous USP [661]
  • Oxygen and Moisture Permeation

Instrumentation/Techniques

  • HPLC:
    • UV/VIS, RI , PDA and Fluorescence
  • LC/MS/MS
  • GC:
    • FID, TCD and ECD
  • Headspace GC
  • GC/MS
  • ICP
  • AA
  • Karl Fischer:
    • Direct and Residual
    • Coulometric
  • FTIR
  • UV/VIS
  • TOC
  • MOCON
  • Dissolution USP [711]
  • Cascade Impactors USP [601]

For more information about Pace Analytical Life Sciences’ Analytical Chemistry Services, please visit the Services page.

Stability Services (ICH)

  • Storage and analysis
25°C/60%RH 30°C/65%RH
30°C/70%RH 40°C/75%RH
  • Custom Conditions available, including Cycling Studies

For more information about Pace Analytical Life Sciences’ Stability Services, please visit the Services page.

Microbiology Services

Facility Support

  • USP Water Testing
  • Environmental Monitoring, including USP [1116]

Non-Sterile Products

  • Microbial Limits, USP [61]
  • Antimicrobial/Preservative Effectiveness Testing, USP [51]
  • Bioburden Testing, USP, EP, JP, AOAC, BP
  • Method Development and Validation, USP [1227]

Organism Identification

  • Rapid Microbial Identification and Characterization Dupont RiboPrinter®
  • Yeasts and Molds
  • Light Microscopy

Sterile Products

  • Bacterial Endotoxins, USP [85] (Gel Clot)
  • Sterility Testing, USP [71]
  • Bacterial Endotoxin, USP [85]
    • Kinetic Method
  • Ethylene Oxide Residual and Analysis
  • Particulate Analysis (HIAC Royco), USP [788]
  • Biological Indicators

For more information about Pace Analytical Life Sciences’ Microbiology Services, please visit the Services page.

Physical Testing

  • Oxygen and Moisture Permeability
  • Static Decay
  • Tensile and Elongation
  • Peel Testing
  • Container/Closure Testing – Seal Strength
  • Adhesion Testing, Pressure Sensitive Adhesive: Instron, Imass Peel Test
  • Hand Rollers
  • Roll Down Machines
  • Temperature/Humidity Controlled Areas

For more information about Pace Analytical Life Sciences’ Physical Testing Services, please visit the Services page.

Additional Services

  • Protocol Development
  • Method Development and Validation
  • Method Transfer and Training
  • Development of Solid/Liquid Drug Delivery Systems
  • Sterilization: E-Beam and Gamma

For more information about Pace Analytical Life Sciences’ Additional Expertise, please visit the Services page.