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Developing Analytical Chromatographic Methods for Pharmaceutical Stability Investigations

30 Nov 2018

This application note describes a case study where Quality by Design approach was used to develop an analytical stability indicating method for monitoring degradation of amoxicillin powder for oral use.

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UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Chromatography Method DevelopmentChromatography method development is the process of designing and optimizing chromatographic techniques to separate and analyze complex mixtures. This includes selecting appropriate stationary and mobile phases, determining flow rates, and optimizing detection methods. Successful method development is essential for high-quality results in fields like pharmaceuticals, food safety, and environmental analysis. Explore chromatography method development tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Method DevelopmentMethod development is the process of creating and optimizing experimental techniques and protocols to achieve reliable, reproducible results. This is essential in various fields, including pharmaceuticals, environmental science, and diagnostics. Browse our peer-reviewed product directory to find the best method development solutions, compare products, check reviews, and get pricing directly from manufacturers.Drug TestingIt is essential to test the efficacy and toxicity of drugs at every stage of their development to ensure that a pharmaceutical product is fit for purpose and safe for use before reaching the stage of mass production and distribution.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.Drug Discovery & Development Screening