Chemical Properties
Denatonium benzoate occurs as an odorless, very bitter tasting, white crystalline powder or granules.
Uses
Pharmaceutic aid (alcohol denaturant); pharmaceutic aid (flavor).
Uses
Denatonium Benzoate Hydrate is a stimulant of the bitter taste receptors which allows for maintenance of the airways. Bronchodilator.
Production Methods
Denatonium benzoate was first synthesized in the 1950s and is usually prepared by reacting denatonium chloride with benzyl benzoate.
brand name
Bitrex (Mac Farlan Smith, Scotland).
Pharmaceutical Applications
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. 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.
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.
LD50 (rabbit, oral): 0.508g/kg
LD50 (rat, oral): 0.584g/kg
storage
Denatonium benzoate is stable up to 140°C 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 retaintheir bitterness forseveral years evenwhenexposed to light.
Incompatibilities
Denatonium benzoateis incompatible with strongoxidizing agents.
Regulatory Status
Denatonium benzoate is used worldwide as a denaturant for alcohol. It is included in the FDA Inactive Ingredients Database (topical gel and solution).
