International Numbering System (INS) for Food Additives:
Food additives Europe numbers: E929
Functional Category:
Solvent
Applications in Pharmaceutical Formulation or Technology
Acetone is used as a solvent or cosolvent in topical preparations,and as an aid in wet granulation.(1,2) It has also been used when formulating tablets with water-sensitive active ingredients, or to solvate poorly water-soluble binders in a wet granulation process.Acetone has also been used in the formulation of microspheres to enhance drug release.(3) Owing to its low boiling point, acetone has been used to extract thermolabile substances from crude drugs.
Description
Acetone is a colorless volatile, flammable, transparent liquid, with a sweetish odor and pungent sweetish taste.
Stability and Storage Conditions
Acetone should be stored in a cool, dry, well-ventilated place out of direct sunlight.
Incompatibilities
Acetone reacts violently with oxidizing agents, chlorinated solvents,and alkali mixtures. It reacts vigorously with sulfur dichloride,potassium t-butoxide, and hexachloromelamine. Acetone should not be used as a solvent for iodine, as it forms a volatile compound that is extremely irritating to the eyes.
Safety
Acetone is considered moderately toxic, and is a skin irritant and severe eye irritant. Skin irritation has been reported due to its defatting action, and prolonged inhalation may result in headaches.Inhalation of acetone can produce systemic effects such as conjunctival irritation, respiratory system effects, nausea, and vomiting.(5)LD50 (mouse, oral): 3.0 g/kg(5) LD50 (mouse, IP): 1.297 g/kg LD50 (rabbit, oral): 5.340 g/kg LD50 (rabbit, skin): 0.2 g/kg