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Analytical Method Development Quantex Laboratories provides comprehensive analytical method development and method validation services. Our knowledgeable and experienced scientists develop methods using a wide range of analytical techniques. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cleaning agents, and raw materials. Method validation is designed collaboratively based upon your specific requirements. Protocols employed can be customer supplied or written by Quantex technical staff using our method validation templates. In the development and validation of stability indication methods, we can perform forced degradation studies on your drug substance or drug product to provide stability validation of the analytical procedures. Routine forced degradation is carried out using acid, base, peroxide, heat, and light. All of our work is performed under strict compliance with cGMP requirements, and our analytical operations are based on formal written, detailed SOPs and stringent quality assurance practices. Upon completion, detailed procedures and results for all method development and method validation projects are presented in a comprehensive report. Our standard format includes a copy of the analytical method, a copy of the protocols when applicable, all test results, appropriate graphs and calculations, and sample raw data (such as chromatograms). In addition reports can be prepare in a customer specified format, both hard copy and electronic/digital.
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