ICH Q3C (R6) Residual solvents

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Current effective version

Adopted guideline

Annexes

Reference numberEMA/CHMP/ICH/82260/2006
Published01/03/2011
Effective from01/08/2011
KeywordsOrganic solvent, impurity, limits, class, reporting levels, permitted daily exposure (PDE), toxicological
DescriptionThis document recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. It recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents.


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