Acetone

• BPAcetone
• Ph. Eur.Acetone
• USP–NFAcetone

Acetonum; dimethylformaldehyde; dimethyl ketone; β-ketopropane; propan-2-one; pyroacetic ether

Propan-2-one · [67-64-1]

UNII 1364PS73AF · PubChem CID 180

C3H6O · 58.08

Solvent, humectant

Typical concentrations: — · Dosage forms: Solid

Used as a process solvent: for dissolving film-coating polymers, in wet granulation of moisture-sensitive drugs, in microsphere and nanoparticle preparation, in extraction, and for cleaning equipment. It is also used as a solvent and degreasing agent in some topical preparations. Because it evaporates rapidly it is largely removed during drying, and residues are controlled as a residual solvent.

A clear, colourless, mobile and very volatile liquid with a characteristic sweetish, fruity odour.

Boiling point

≈ 56 °C

Melting point

≈ −95 °C

Density

≈ 0.79 g/cm³ at 20 °C

Flash point

about −20 °C (closed cup); highly flammable

Solubility

miscible with water, ethanol, ether, chloroform and most organic solvents

Stable when kept in a well-closed container in a cool, well-ventilated place away from heat, sparks and direct sunlight.

Reacts vigorously with strong oxidising agents (for example hydrogen peroxide, nitric acid, chromic acid), with chlorinating agents and with strong alkalis such as potassium tert-butoxide. With chloroform in the presence of a base it can react violently. It dissolves or softens many plastics and rubbers.

Produced mainly as a co-product of the cumene process for phenol; it can also be made by dehydrogenation of isopropyl alcohol. Pharmaceutical grades are purified by fractional distillation.

Acetone has low systemic toxicity, and its residues in medicines are of little concern within ICH limits. Repeated contact defats and irritates the skin, the liquid irritates the eyes, and inhalation of high vapour concentrations causes headache, dizziness and central nervous system depression.

Highly flammable: use in a well-ventilated area or under local exhaust, away from ignition sources, with earthed equipment to avoid static discharge. Gloves and eye protection are recommended. Vapour is heavier than air and may travel to a distant ignition source.

Classified as an ICH Q3C Class 3 residual solvent (low toxic potential). Included in the FDA Inactive Ingredient Database (oral tablets and topical preparations) and in non-parenteral medicines licensed in Europe.

No closely related excipient; other volatile process solvents include ethanol, isopropyl alcohol and ethyl acetate.

Acetone–water and acetone–ethanol mixtures are common solvents for coating with cellulose esters and acrylic polymers. Its high volatility allows fast drying but can cause blushing of films or crust formation in granules if drying conditions are not controlled.