Risk assessment-based control strategy for residual solvents in chemical drugs
HUANG Chao-yu
YAN Fei
YAO Zhi-yu
SHAO Fang-xiang
LI Rui
WANG Yu
Abstract：In alignment with ICH Q3C guidelines and with reference to the implementation requirements of major international pharmacopoeias,a risk assessment was performed based on the evaluation of raw materials,excipients,and production processes to investigate potential residual solvents in pharmaceutical products.This study explores a harmonization strategy for harmonizing the control of residual solvents in chemical drugs under the Chinese Pharmacopoeia(VolumeⅡ)with ICH Q3C guidelines.The proposed approach aims to serve as a reference for the systematic harmonization of ICH Q3C within the monographs of ChP Volume Ⅱ and to provide technical guidance for regulatory authorities in advising manufacturers on conducting risk assessments for residual solvents.
Keywords：chemical drugresidual solventsICHcontrol strategy
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( 1-5 )