Chemical Substance - Acetone

NHPID name:
Acetone

Reference:
MIO

Proper name(s):

Common name(s):
Acetone

Category:
Approved Chemical Name
Structure:
Image of molecular structure representing Acetone


Schedule 1:
Isolate

CAS registry number:
67-64-1




Toxicity restriction:

Upper limit:
50.0

Units:
Milligrams/24 hour

Detail:
Up to 50 mg/day as residual solvent without justification, equivalent to a concentration limit of 5000 ppm when assuming a product mass of 10 g administered daily. This limit applies to all dosage forms and routes of administration.

Related links:

Reference:
ICH


Roles

Medicinal

Rationale:

Classified as an NHP under Schedule 1, item 2 (an isolate) of the Natural Health Products Regulations.

Reference:  NNHPD

Non-medicinal

Purposes:
Denaturant , Flavour Enhancer , Solvent
Restrictions:

General:

Route Of administration:
Oral

Allowed purposes:
Flavour Enhancer

Reference:
FHFI_2010


General:

Route Of administration:
Topical

Allowed purposes:
Denaturant

Detail:
Up to 10%.

Reference:
DSDAR

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