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Determination of residual organic solvents in pharmaceuticals by headspace gas chromatography

机译:顶空气相色谱法测定药物中的残留有机溶剂

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摘要

A determination method of residual solvents in pharmaceutical products by headspace gas chromatography has been established and optimized. Eight solvents which belong to the guideline for residual solvents regulated by the International Conference on Harmonization were studied. Under optimum conditions, various components were separated completely. This novel method was applied to the analysis of volatile residual solvents in pharmaceutical products with satisfactory results. The method is simple, accurate and reliable, which can be used to detect the residual solvents in pharmaceutical products.
机译:建立并优化了顶空气相色谱法测定药品中残留溶剂的方法。研究了属于国际协调会议规定的残留溶剂指南的八种溶剂。在最佳条件下,各种组分被完全分离。该新方法用于药物产品中挥发性残留溶剂的分析,结果令人满意。该方法简单,准确,可靠,可用于检测药品中的残留溶剂。

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