Analytical Method Development For Iso Propyl Alcohol Content In Lysine Monohydrate By GC-HS
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Abstract
A simple, sensitive, accurate, robust headspace gas chromatographic method was developed for the quantitative determination of isopropyl alcohol in Lysine. The method validation was carried out with regard to the guidelines for validation of analytical procedures Q2 demanded by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). All the validation characteristics were meeting the acceptance criteria. Hence, the developed and validated method can be applied for the intended routine analysis.
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References
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