International Numbering System (INS) for Food Additives: 950
Food additives Europe numbers: E950
Functional Category
Sweetening agent.
Applications in Pharmaceutical Formulation
Acesulfame potassium is used as an intense sweetening agent in cosmetics, foods, beverage products, table-top sweeteners, vitamin and pharmaceutical preparations, including powder mixes, tablets, and liquid products. It is widely used as a sugar substitute in compounded formulations,(1) and as a toothpaste sweetener.(2) The approximate sweetening power is 180–200 times that of sucrose, similar to aspartame, about one-third as sweet as sucralose, one-half as sweet as sodium saccharin, and about 4-5 times sweeter than sodium cyclamate.(3) Ienhances flavor systems and can be used to mask some unpleasant taste characteristics
Description
Acesulfame potassium occurs as a colorless to white-colored, odorless, crystalline powder with an intensely sweet taste.
Stability and Storage Conditions
Acesulfame potassium possesses good stability. In the bulk form it shows no sign of decomposition at ambient temperature over many years. In aqueous solutions (pH 3.0–3.5 at 208C) no reduction in sweetness was observed over a period of approximately 2 years. Stability at elevated temperatures is good, although some decomposition was noted following storage at 408C for several months. Sterilization and pasteurization do not affect the taste of acesulfame potassium.(7) The bulk material should be stored in a well-closed container in a cool, dry place and protected from light.
Incompatibilities: -
Safety
Acesulfame potassium is widely used in beverages, cosmetics, foods, and pharmaceutical formulations, and is generally regarded as a relatively nontoxic and nonirritant material. Pharmacokinetic studies have shown that acesulfame potassium is not metabolized and is rapidly excreted unchanged in the urine. Long-term feeding studies in rats and dogs showed no evidence to suggest acesulfame potassium is mutagenic or carcinogenic.(9) The WHO has set an acceptable daily intake for acesulfame potassium of up to 15 mg/kg body-weight.(9) The Scientific Committee for Foods of the European Union has set a daily intake value of up to 9 mg/kg of body-weight.(3) LD50 (rat, IP): 2.2 g/kg(7) LD50 (rat, oral): 6.9–8.0 g/k