Chemical Substance - Methyl isobutyl ketone

NHPID name:
Methyl isobutyl ketone

Reference:
USP-NF Online

Proper name(s):
4-Methyl-2-pentanone

Common name(s):

Category:
Approved Chemical Name
CAS registry number:
108-10-1




Toxicity restriction

Upper limit:
45.0

Units:
Milligrams/24 hour

Detail:
Permitted daily exposure as residual solvent up to 45 mg/day, equivalent to a concentration limit of 4500 ppm when assuming a product mass of 10 g administered daily. This limit applies to all dosage forms and routes of administration.

Reference:
ICH


Roles

Non-medicinal

Purposes:
Denaturant , Flavour Enhancer
Restrictions:

General

Route Of administration:
Oral

Allowed purposes:
Flavour Enhancer

Detail:
Up to 25 ppm.

Reference:
FHFI_2010


General

Route Of administration:
Topical

Allowed purposes:
Denaturant

Detail:
Up to 4%.

Reference:
CIR