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
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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
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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