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Sodium cyclamate
سدیم سیکلامات
1Nonproprietary names
- BPSodium Cyclamate
- Ph. Eur.Sodium Cyclamate
2Synonyms and trade names
Cyclamate sodium; cyclohexylsulfamic acid monosodium salt; natrii cyclamas; sodium cyclohexylsulfamate; E952
3Chemical name and CAS Registry Number
Sodium N-cyclohexylsulfamate · [139-05-9]
UNII 1I6F42RME1 · PubChem CID 23665706
4Empirical formula and molecular weight
C6H12NNaO3S · 201.22
5Functional category
Sweetening agent
Typical concentrations: — · Dosage forms: Liquid, Solid
6Applications in pharmaceutical formulation
Sodium cyclamate is an intense sweetener used in oral liquids, chewable and effervescent tablets, powders and table-top sweeteners. It is about 30 times as sweet as sucrose and is commonly combined with saccharin (classically in a 10:1 ratio), which masks the bitter aftertaste of saccharin and gives a synergistic sweetening effect. It is used at low concentrations, typically a few tenths of a per cent or less.
7Description
White, odourless or almost odourless crystals or crystalline powder with an intensely sweet taste. It is non-hygroscopic.
8Typical properties
- Relative sweetness
- about 30 times that of sucrose
- Solubility
- freely soluble in water; slightly soluble in ethanol; practically insoluble in chloroform and ether
- pH
- 5.5–7.5 (10% w/v aqueous solution)
- Heat stability
- stable to heat, light and air over a wide pH range; suitable for cooked and baked products
9Stability and storage conditions
Stable to heat, light and air across a wide pH range in both the solid state and in solution. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Few incompatibilities have been reported; it is incompatible with strong oxidising agents. Nitrites can react with it in acidic media.
11Method of manufacture
Prepared by sulfonation of cyclohexylamine (for example with sulfamic acid or sulfur trioxide) followed by neutralisation with sodium hydroxide, and purified by crystallisation.
12Safety
Most cyclamate is excreted unchanged, but in some individuals gut bacteria convert part of it to cyclohexylamine, which is the basis of the acceptable daily intake. Cyclamate was banned as a food additive in the USA in 1970 after studies in rats suggested bladder tumours; later studies did not confirm a carcinogenic risk. JECFA has set an ADI of 0–11 mg/kg body-weight (as cyclamic acid), and the EU an ADI of 7 mg/kg body-weight.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and gloves are recommended.
14Regulatory status
Accepted as a food additive in Europe (E952) and in many other countries, but not permitted in foods in the USA. Included in non-parenteral medicines licensed in Europe and other regions.
15Related substances
Calcium cyclamate; cyclamic acid; saccharin sodium; aspartame; acesulfame potassium.
16Comments
Its regulatory status differs between countries, so confirm acceptability in each target market before use, especially for products intended for export to the USA. Combining it with other sweeteners lowers the amount required.