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International Conference on Harmonisation; final recommendation for the revision of the permitted daily exposure for the solvent cumene according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; availability. Notice.

Federal register (2012-03-03)
ABSTRACT

The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Cumene, 98%
Supelco
Cumene, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Cumene, PESTANAL®
Supelco
Cumene solution, certified reference material, 5000 μg/mL in methanol