Method Development & Validation
Quantex laboratories has the resources and flexibility to develop analytical methods or to remediate existing analytical methods tailored to your specific needs. Our laboratory has 25 years of in depth experience with designing and executing method development and validation, verification and method transfer protocols and experiments. Our knowledgeable, experienced and responsive analytical team develops methods that are rugged, robust, stability indicating and fit for purpose using a wide range of analytical techniques. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cosmetics, personal care producuts, and raw materials. In the development and validation of stability indication methods, we can perform forced degradation studies on your drug substance or product to provide stability validation of the analytical procedures. Routine forced degradation is also carried out using acid, base, peroxide, heat, and light. Over the years, our analytical team has successfully developed-validated-transferred in excess of 2,000 chromatography (HPLC/GC/MS), spectroscopy (AAS/ICP/ICP-MS) or other chemistry analytical procedures, including several now in the USP.
All of our work is performed under FDA, EMA, USP, cGMP and ISO guidelines and requirements:
- All analytical work is performed under strict compliance with cGMP requirements. Our analytical operations are based on formal written, detailed SOPs and stringent quality assurance practices in compliance with FDA, ICH and ISO regulations, requirements and guidance.
- Are carried out by qualified personnel equipped with adequate resources. Our senior scientists average over 30 years of experience in regulated chemistry operations (R&D,GMP).
- Well-equipped state-of-the-art facilities able to handle projects of any size, scope or complexity.
- Subject to development/validation/transfer (written) protocols jointly developed by both the client and by Quantex.
- Effective and efficient collaboration between our analytical team and yours.
- Comprehensive final report with detailed procedures and findings signed off by Quantex’s scientific management and QA, and your analytical and QA team.
- Our standard report format includes a copy of the analytical method, a copy of the protocols, all test results, appropriate graphs and calculations, and sample raw data (i.e chromatograms, calibrations).
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