Analysis of USP Residual Solvents with Improved Repeatability Using Static Headspace-Gas Chromatogr

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  Residual solvents in pharmaceuticals are organic volatile impurities that are used or produced in the manufacture of drug substances.In order to protect patient safety less toxic solvents should be used when possible.Residual solvents should be controlled at acceptable limits as established by regulation.Static Headspace-Gas chromatography (static HS-GC) is the preferred technique for analysis of residual solvents.Residual solvent levels are controlled by various regulatory agencies and pharmacopoeias, such as United States Food Drug Administration (US FDA) and United States Pharmacopoeia (USP).In USP <467>, the method based on static HS-GC establishes the guideline for residual solvents analysis.However, this method has historically suffered from poor repeatability and sensitivity when analyzing solvents using previous generation headspace samplers.
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