FDA Guidance for Industry: Q3C(R8) Impurities:Guidance for Residual Solvents
Titel:
FDA Guidance for Industry: Q3C(R8) Impurities:Guidance for Residual Solvents
Internet:
Herkunft/Verlag:
FDA
Inhalt:
This guidance provides recommendations for permitted daily exposures (PDEs) for three
additional residual solvents: (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3)
tert-butyl alcohol.