PharmaVault
گنجینه اطلاعات داروسازی
The Pharmaceutical Information Vault
Excipient monograph · مونوگراف ماده جانبی
pharmavault.ir
Acesulfame potassium
آسهسولفام پتاسیم
1Nonproprietary names
- BPAcesulfame Potassium
- Ph. Eur.Acesulfame Potassium
- USP–NFAcesulfame Potassium
2Synonyms and trade names
Acesulfame K; acesulfamum kalicum; Sunett; E950
3Chemical name and CAS Registry Number
6-Methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide potassium salt · [55589-62-3]
4Empirical formula and molecular weight
C4H4KNO4S · 201.24
5Functional category
Sweetening agent
Typical concentrations: — · Dosage forms: Solid, Liquid
6Applications in pharmaceutical formulation
An intense sweetener used in oral liquids, chewable and orodispersible tablets, powders for reconstitution, mouthwashes and many foods and beverages. It is often blended with aspartame or sucralose, because the combination gives a more sugar-like taste profile and a synergistic increase in sweetness. Levels are set by taste, typically a few hundredths to a few tenths of a per cent in the finished product.
7Description
A white, odourless, crystalline powder with an intensely sweet taste. At high concentrations a slightly bitter or metallic aftertaste may be noticed.
8Typical properties
- Sweetness
- about 180–200 times that of sucrose
- Solubility
- freely soluble in water; very slightly soluble in ethanol and acetone
- Thermal behaviour
- no sharp melting point; decomposes only at high temperature (well above normal processing temperatures, around 200 °C or more)
- Hygroscopicity
- non-hygroscopic under normal storage conditions
9Stability and storage conditions
Very stable in the solid state and in solution over the pH range of most foods and medicines, and it tolerates pasteurisation and baking temperatures. Store in a well-closed container in a cool, dry place.
10Incompatibilities
No significant incompatibilities with common excipients have been reported.
11Method of manufacture
Produced synthetically from an acetoacetic acid derivative (such as diketene) and sulfamic acid; the intermediate is cyclised with sulfur trioxide and the resulting acid is neutralised with potassium hydroxide, then purified by crystallisation.
12Safety
It is not metabolised and is excreted unchanged, mainly in the urine, so it provides no energy. It is regarded as non-toxic at the levels used. JECFA has set an ADI of 0–15 mg/kg body weight, and EFSA's re-evaluation of E950 also concluded on an ADI of 15 mg/kg body weight.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended, and dust generation should be minimised.
14Regulatory status
Approved by the FDA as a general-purpose sweetener in foods (it is a food additive, not a GRAS substance). Accepted as a food additive in Europe (E950). Included in the FDA Inactive Ingredient Database (oral preparations) and in non-parenteral medicines licensed in Europe.
15Related substances
Aspartame; neotame; saccharin; saccharin sodium; sucralose; aspartame–acesulfame salt.
16Comments
Because it is heat- and pH-stable, acesulfame potassium is useful in products that are heated during manufacture or have a long shelf-life in solution. Its bitter aftertaste at higher levels is best masked by combining it with another sweetener and suitable flavours.