Supercritical fluid chromatography for pharmaceutical quality control: Current challenges and perspectives

TrAC Trends in Analytical Chemistry(2022)

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摘要
Quality control is a fundamental and critical activity in the pharmaceutical industry that permits to guarantee the quality of medicines and consequently safeguard the health of the patients. In recent years, supercritical fluid chromatography has emerged as a robust and suitable analytical technique in several fields thanks to the introduction of modern SFC instruments. The present review aims to give an overview of the recent advances of the use of SFC in pharmaceutical quality control and highlights current challenges and perspectives. SFC instrumentation is presented and published applications are discussed from an analytical method lifecycle point of view. At each step regulatory requirements and recommendations are also presented to highlight the readiness of modern SFC for pharmaceutical QC.
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关键词
Supercritical fluid chromatography (SFC),Mass spectrometry (MS),Pharmaceutical quality control (QC),Good manufacturing practices (GMP),Analytical method lifecycle,Validation,Quality by Design (QbD)
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