For 25 years Quantex has been involved with developing and validating HPLC methods used to monitor the synthesis and release of drug substances and drug products. Our analytical team has a proven track record of developing methods for oral dosage forms, parenterals, ointments, creams, coated stents and implantables, as well as methods for OTC products.
Our scientists develop analytical methods that are robust, transferable, reproducible, and designed to support and meet regulatory requirements and submissions. Quantex’s method development services ensure that your team makes the best decisions and hits drug development milestones on time and on budget.
Our approach is to work closely with each client collaboratively, to fully understand both the requirements of the method and the nature of the compound(s). Then, through our unique blend of experience, expertise, and focus we evaluate parameters and identify critical quality attributes. Supporting this is our state-of-the-art HPLC laboratories with 18 HPLC/UPLC systems. This allows us to develop HPLC methods that are robust, efficient, stability-indicating, fit for purpose, ranged properly, and that can be quickly validated.
METHOD DEVELOPMENT SERVICES
Purity, potency (assay), related substances and impurities quantification
Stability indicating methods.
Robust methods for fast method transfer.
Methods utilizing a wide range of detection modes.
Molecules with unique complexity or physical properties.
cGMP Raw Material testing.
API Release testing.
Reference Standard Qualification.
Final Product Release testing.
ICH Stability Programs
6 Agilent 1100 HPLC systems with degasser, thermostated autosampler, quaternary pump, column oven and photodiode array detector, additional detectors RI, ELSD and FL.
2 Agilent 1200 HPLC systems with degasser, thermostated autosampler, quaternary pump, column oven and photodiode array detector, additional detectors RI, ELSD and FL.
1 Agilent 1050 HPLC System with degasser, autosampler, quaternary pump, column oven and MWV Detector.
4 Shimadzu LC2010C HT HPLC Systems with degasser, thermostated autosampler, quaternary pump, column oven and UV detector, additional detectors, RI, ELSD.
1 Perkin Elmer Series 200 HPLC system with degasser, thermostated autosampler, quaternary Pump, column oven, UV detector and ELSD.
1 Perkin Elmer Series 200 HPLC system with degasser, thermostated autosampler, quaternary pump, column oven, electrochemical detector, coulometric detector and pulsed amperometric detectors.
1 Perkin Elmer 200 with degasser, isocratic pump, autosampler, column oven, UV detector and RI detector.
Waters ILC-2 IC system with inline degasser, isocratic pump, suppressor and conductivity detector.
Waters Acquity I Series UPLC with in-line degasser, binary solvent manager, sample manager & organizer, column manager/oven and PDA.
For more information about our QC Lab Testing Capabilities – or for answers to questions about any of our analytical services – contact Angela Parisi-Menoutis by email or by phone at 609.655.4047 x 303.
Analytical Method Development & Validation • Impurities Contaminant Identification • Residual Solvents • Stability & Shelf Life Services • Extractables and Leachables • Product Quality Control & Release Testing • cGMP Compendial/Raw Materials Testing • Cosmetics Products Testing Services • QC & Routine Testing • Elemental Impurities • Strict Compliance with cGMP and GLP Requirements
FDA Registered & Inspected •ISO/IEC 17025:2005 Accredited
A Fully Audited and Approved Contract Analytical Services Vendor
Johnson & Johnson Globally Quality Approved Analytical Vendor / Johnson & Johnson Consumer Products Company / Colgate Palmolive Company / Proctor & Gamble / Impax Labs / Ethicon / McNeil / Atrium Medical / Smith & Nephew / Claris / DR.Reddy's / BD / L'Oreal /MyLan / Revlon / Hartz / BASF / And Many More