Instrument and Analytical Capabilities
All work performed by Quantex utilizes state-of-the-art instrumentation with an extensive range of analytical techniques and instrumental capabilities. Our laboratories provide analytical testing in support of development through manufacturing. This includes method development, validation, raw materials and excipients testing, in-process and release testing, stability testing, extractables and leachables, as well as for both organic and inorganic impurities, contaminants and unknowns. Our facility provides extensive laboratory capacity and advanced scientific tools, allowing us to manage projects of any size and scope and provide the most innovative, cost-effective and timely scientific solutions.
Our facility is fully cGMP compliant, ISO 17025 accredited, and our instruments undergo periodic calibration, qualification, validation, and preventive maintenance to assure ongoing compliance with cGMP and GLP regulations. All computerized systems are compliant with 21 CFR Part 11.