The change of analytical procedure, a part of the entire lifecycle of a method, is increasingly valued with the emergence of new technologies, the increasing demand for product quality, 3R, environmental protection, and cost reduction requirements. This paper refers to the latest progress in the study of counterpart law at home and abroad, systematically classifies changes of analytical procedures from the perspective of methodology, and discusses the differences between different types of changes and the evaluation criteria and implementation approaches of analytical procedures after procedure changes.
ZHU Rong-die, GENG Ying, DU Ying, TAN De-jiang, CHEN Hua, QIU Zhi-jun
. Discussion on the classification, acceptance criteria and assessment approaches of the change of analytical procedure[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(4)
: 562
-566
.
DOI: 10.16155/j.0254-1793.2024.04.02
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