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Sucralose
سوکرالوز
1Nonproprietary names
- BPSucralose
- Ph. Eur.Sucralose
- USP–NFSucralose
2Synonyms and trade names
1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside; trichlorogalactosucrose; TGS; Splenda; E955
3Chemical name and CAS Registry Number
1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactopyranoside · [56038-13-2]
UNII 96K6UQ3ZD4 · PubChem CID 71485
4Empirical formula and molecular weight
C12H19Cl3O8 · 397.64
5Functional category
Sweetening agent
Typical concentrations: — · Dosage forms: Liquid, Solid
6Applications in pharmaceutical formulation
An intense sweetener, roughly 600 times as sweet as sucrose (300–1000 times depending on the system), used in oral solutions, suspensions, syrups, chewable and orally disintegrating tablets, powders and foods. It has a clean, sugar-like taste with little aftertaste and is often combined with other sweeteners and flavours. Because of its potency it is used at low concentrations, usually well below 0.5% w/w.
7Description
A white to off-white, practically odourless, free-flowing crystalline powder with a sweet taste.
8Typical properties
- Solubility
- freely soluble in water, methanol and ethanol; slightly soluble in ethyl acetate
- Relative sweetness
- about 600 times that of sucrose
- Thermal behaviour
- melts with decomposition at about 125–130 °C; the dry solid darkens on prolonged heating
- Water content
- not more than 2%
9Stability and storage conditions
Very stable in aqueous solution over the pH and temperature ranges used in foods and pharmaceuticals; slow hydrolysis to its monosaccharide components (4-chloro-4-deoxygalactose and 1,6-dichloro-1,6-dideoxyfructose) occurs only under prolonged acidic, high-temperature conditions. The dry powder can discolour and release hydrogen chloride when heated strongly. Store in a well-closed container in a cool, dry place.
10Incompatibilities
No significant incompatibilities have been reported; avoid prolonged exposure to high temperatures in the dry state.
11Method of manufacture
Made from sucrose by a multistep process in which some hydroxyl groups are temporarily protected (for example as an ester), three specific hydroxyl groups are selectively replaced by chlorine, and the protecting groups are removed before crystallisation.
12Safety
Only a small fraction of an oral dose is absorbed, and most is excreted unchanged in the faeces. It is not metabolised for energy and is non-cariogenic. JECFA and the former EU Scientific Committee on Food set an acceptable daily intake of 0–15 mg/kg body weight.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and a dust mask are recommended where dust is generated.
14Regulatory status
Approved by the FDA as a general-purpose sweetener in foods. Accepted in Europe as a food additive (E955). Included in the FDA Inactive Ingredient Database (oral preparations) and in non-parenteral medicines licensed in Europe.
15Related substances
Acesulfame potassium; aspartame; saccharin; saccharin sodium; sucrose.
16Comments
Sucralose is non-hygroscopic and, unlike aspartame, does not degrade in acidic liquids or at baking temperatures, which makes it convenient for oral liquids with long shelf lives. Its bitterness-masking ability is limited, so it is usually used together with flavours.