Extractables and Leachables

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

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  • Expertise in designing controlled extraction studies:

o    OINDP: Orally Inhaled & Nasal Drug Product

o    PMDI: Pressurized Metered Dose Inhalers
o    DPI: Dry Powder Inhalers
o    Syringes

o    Single Use Systems (bags, tubing, connectors and filters)
o    CCS: Container Closure Systems
o    Vials and Stoppers
o    Parenterals
o    Implantables
o    Infusion Pump

  • Expertise in developing and validating leachable methods in a wide variety of drug product(s):

o    Nasal Sprays (Aqueous and Organic Based)
o    HFA products
o    Injectables
o    Intramucosal products
o    Lyophilized products
o    Biologic

  • Dedicated facilities and equipment:

o    GC/MSD & GC/MS/MS
o    Headspace GC/NPD & GC/FID & GC/MSD & GC/MS/MS
o    HPLC/DAD/FLD/RID/MSD & HPLC/MS/MS & HPLC/MS-QTOF & UPLC
o    LC/IC
o    UV-Vis
o    Total Organic Carbon (TOC)
o    Microwave Extraction Oven
o    Reflux
o    Soxhlet
o    High Speed Mill
o    Hydraulic Press
o    Shaking Incubators