Article
Development And Validation Of A Quantitative Method For Six Residual Solvents In A Propylene Glycol Matrix By Gas Chromatography
December 20, 2006
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Abstract
A gas chromatography (GC) method was developed to quantitate six residual solvents present in a propylene glycol matrix using a single assay. The solvents tested include ethanol, isopropanol, acetone, isobutanol, 1-butanol, and tert-butanol. Each solvent is a component in adhesives used to attach labels to pre-filled polymeric syringes.
The method is used as a leachable/extractable assay for the drug product during stability testing. Validation activities established a working range of 0.2-15 ppm for each solvent, with an obtained linearity correlation coefficient greater than 0.999.
The method was shown to be accurate, precise, robust, and specific for its intended use. This method has the potential to be used for a wide range of pharmaceutical and environmental applications.
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•Power Point Presentation: Development And Validation Of A Quantitative Method For Six Residual Solvents In A Propylene Glycol Matrix By Gas Chromatography
SOURCE: Hospira One 2 One
