Functional Category
Alcohol denaturant; flavoring agent.
Applications in Pharmaceutical Formulation
Denatonium benzoate is among the most bitter of substances known and is detectable at concentrations of approximately 10 ppb. In pharmaceutical and other industrial applications it is added to some products as a deterrent to accidental ingestion.(1–4) It is most commonly used at levels of 5–500 ppm. Denatonium benzoate may also be used to replace brucine or quassin as a denaturant for ethanol. In pharmaceutical formulations, denatonium benzoate has been used as a flavoring agent in placebo tablets, and in a topical formulation it has been used in an anti-nailbiting preparation.(5)
Description
Denatonium benzoate occurs as an odorless, very bitter tasting, white crystalline powder or granules.
Stability and Storage Conditions
Denatonium benzoate is stable up to 1408C and over a wide pH range. It should be stored in a well-closed container (such as polythene-lined steel) in a cool, dry place. Aqueous or alcoholic solutions retain their bitterness for several years even when exposed to light.
Incompatibilities
Denatonium benzoate is incompatible with strong oxidizing agents.
Safety
Denatonium benzoate is generally regarded as a nonirritant and nonmutagenic substance. However, there has been a single report of contact urticaria attributed to denatonium benzoate occurring in a 30-year-old man who developed asthma and pruritus after using an insecticidal spray denatured with denatonium benzoate.(6) LD50 (rabbit, oral): 0.508 g/kg(7) LD50 (rat, oral): 0.584 g/kg