Co-Sense for Impurities

Liquid Chromatograph with online Sample Preparation

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Co-Sense for Impurities

FDA 指引草案中，「藥物原料和產品中的基因毒性與致癌雜質：建議方法」(Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches) 規定了原料藥中遺傳毒性雜質的允許限值。這些雜質需要比普通雜質更靈敏的微量分析。通常，質譜儀方法，例如 GC/MS 或 LC/MS，可應用於雜質的高靈敏度分析。然而，越來越需要建立一種使用吸光度或其他常規檢測器的高靈敏度定量方法，這些檢測器易於操作並且可以輕鬆應用於現有的 LC 分析條件。

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