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  • Title: Measurement of residual solvents in a drug substance by a purge-and-trap method.
    Author: Lakatos M.
    Journal: J Pharm Biomed Anal; 2008 Aug 05; 47(4-5):954-7. PubMed ID: 18436411.
    Abstract:
    The purge-and-trap (P&T) gas extraction method combined with gas chromatography was studied for its suitability for quantitative residual solvents determination in a water-soluble active pharmaceutical ingredient (API). Some analytical method performance characteristics were investigated, namely, the repeatability, the accuracy and the detection limit of determination. The results show that the P&T technique is--as expected--more sensitive than the static headspace, thus it can be used for the determination of residual solvents pertaining to the ICH Class 1 group. It was found that it could be an alternative sample preparation method besides the static headspace (HS) method.
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