Dimethylacetamide

• BPDimethylacetamide
• Ph. Eur.Dimethylacetamide
• USP–NFDimethylacetamide

acetic acid dimethylamide; acetyldimethylamine; DMA; DMAC; N,N-dimethylacetamide

N,N-Dimethylacetamide · [127-19-5]

UNII JCV5VDB3HY · PubChem CID 31374

C4H9NO · 87.12

Solvent, humectant

Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic)

Used as a solvent for poorly water-soluble drugs in parenteral products, usually combined with other cosolvents; for example, intravenous busulfan concentrate uses dimethylacetamide (about one-third of the vehicle) with polyethylene glycol 400. It is also used as a process solvent in pharmaceutical manufacture and for polymers and fibres.

A clear, colourless, slightly hygroscopic liquid with a faint amine-like odour.

Boiling point

about 165 °C

Melting point

about −20 °C

Density

about 0.94 g/cm³ at 20 °C

Solubility

miscible with water, ethanol, ether, ketones, esters and aromatic hydrocarbons

Stable under normal conditions; it is slowly hydrolysed by strong acids and bases to acetic acid and dimethylamine. Store in an airtight container, protected from light and moisture, in a cool, well-ventilated place.

Incompatible with strong oxidising agents, strong acids and bases, and some halogenated hydrocarbons. It attacks many plastics, including polycarbonate, so infusion sets, syringes and filters used with concentrates containing it must be compatible.

Made by reacting dimethylamine with acetic acid, acetic anhydride or methyl acetate, followed by purification by distillation.

Readily absorbed through the skin and by inhalation. High exposures cause liver toxicity and central nervous system effects such as lethargy and hallucinations, and it is classified in the EU as toxic to reproduction. As an ICH Q3C Class 2 solvent its permitted daily exposure is 10.9 mg/day (limit 1090 ppm).

Wear impervious gloves, eye protection and protective clothing and handle in a fume cupboard or with good ventilation; women of child-bearing potential should avoid exposure. Combustible liquid.

ICH Q3C Class 2 residual solvent. Included in the FDA Inactive Ingredient Database (intravenous and intramuscular injections) and in parenteral medicines licensed in Europe.

Dimethyl sulfoxide; dimethylformamide; N-methylpyrrolidone; polyethylene glycol 400.

The daily amount given in a parenteral product should be justified against toxicity data, especially for high-dose regimens such as conditioning before stem-cell transplantation. Concentrates usually need dilution before infusion, and the drug may precipitate if the dilution ratio is not followed.