【摘 要】
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Direct analysis in real time mass spectrometry (DART-MS) method has been developed using the Quality by Design (QbD) principle.In this presented approach, m
【机 构】
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浙江大学药学院药物信息学研究所,杭州310058
论文部分内容阅读
Direct analysis in real time mass spectrometry (DART-MS) method has been developed using the Quality by Design (QbD) principle.In this presented approach, method performance was mathematically described as a composite desirability function of the critical quality attributes (CQAs).Two terms of method validation, including analytical repeatability and method robustness, were carried out at an operating work point.This presented strategy provided a tutorial to the development of a robust QbD compliant mass spectrometry method for industrial quality control.
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