Analytical Services


Extractables and Leachables


Our extractables and leachables analysis, and container closure testing capabilities, are key components of the extensive contract chemistry services we offer our clients.


  • Expertise in designing controlled extraction studies
    • OINDP: Orally Inhaled & Nasal Drug Product
    • PMDI: Pressurized Metered Dose Inhalers
    • DPI: Dry Powder Inhalers
    • Syringes
    • Single Use Systems (bags, tubing, connectors and filters)
    • CCS: Container Closure Systems
    • Vials and Stoppers
    • Parenterals
    • Implantables
    • Infusion Pumps
  • Expertise in developing and validating leachable methods in a wide variety of drug product(s):
    • Nasal Sprays (Aqueous and Organic Based)
    • HFA products
    • Injectables
    • Intramucusal products
    • Lyophilized products
    • Biologic’s
  • Dedicated facilities and equipment:
    • GC/MSD & GC/MS/MS
    • Headspace GC/NPD & GC/FID & GC/MSD
    • HPLC/DAD/MSD & HPLC/MS/MS & HPLC/MS (Ion Trap) & UPLC
    • LC/IC
    • Total Organic Carbon (TOC)
    • Microwave Extraction Oven
    • Reflux
    • Soxhlet
    • High Speed Mill
    • Hydraulic Press