AQbD-based analysis and case studies:interpretation of Chinese Pharmacopoeia and ICH Q2 analytical procedure validation guidelines
SHAO Fang-xian
HUANG Chao-yu
YAN Fei
WANG Yu
LI Rui
Abstract：Both ICH Q2 guidelines and the general chapter<9101>of the 2025 Chinese Pharmacopoeia are of significant value for analytical procedure development and validation.By comparing and interpreting these regulatory guidelines,and through practical validation examples,this paper explores Analytical Quality by Design(AQbD)-based analytical procedure validation strategies.This study aims to provide reference and insights for pharmaceutical analysis and drug quality control practices.
Keywords：analytical quality by designprocedure validationguidelines
Publication Date：2026-01-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 6-10 )