Saccharin sodium

• BPSaccharin Sodium
• JPSaccharin Sodium Hydrate
• Ph. Eur.Saccharin Sodium
• USP–NFSaccharin Sodium

1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt; Crystallose; saccharinum natricum; sodium o-benzosulfimide; soluble gluside; soluble saccharin; E954

1,2-Benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt · [128-44-9]

UNII I4807BK602 · PubChem CID 656582

C7H4NNaO3S (anhydrous); hydrated forms, mainly C7H4NNaO3S·2H2O · 205.16 (anhydrous); 241.19 (dihydrate)

Sweetening agent

Typical concentrations: — · Dosage forms: Liquid, Solid

The most commonly used form of saccharin in pharmaceuticals because of its high water solubility. It sweetens oral solutions, syrups, suspensions, effervescent and chewable tablets, mouthwashes and dentifrices, and is often combined with other sweeteners and flavours to mask its aftertaste. Typical concentrations in oral liquids are about 0.04–0.6% w/v.

White, odourless or faintly aromatic, efflorescent crystals or a white crystalline powder with an intensely sweet taste and a metallic aftertaste at higher concentrations. It is about 300–600 times as sweet as sucrose. The commercial material is usually a hydrate.

Solubility

freely soluble in water (about 1 in 1.2); sparingly soluble in ethanol

pH

about 6.5 (10% w/v aqueous solution)

Water content

up to about 15% w/w, depending on the hydrate form

Melting point

decomposes above 300 °C

Stable under normal conditions of use; aqueous solutions withstand autoclaving and are stable over the pH range used in most oral liquids. Hydrolysis becomes significant only under strongly acidic conditions at high temperature. The crystals may effloresce in dry air; store in a well-closed container.

In strongly acidic liquids, free saccharin, which is much less soluble, may precipitate. Avoid strong oxidising agents.

Prepared by neutralising saccharin with sodium hydroxide or sodium hydrogen carbonate in aqueous solution and crystallising the salt.

Its safety profile is that of saccharin: it is not metabolised, is excreted unchanged, and the bladder tumours seen in rats at very high doses are not considered relevant to humans. JECFA has set an acceptable daily intake of 0–5 mg/kg body weight for saccharin and its salts. It contributes a small amount of sodium.

Observe normal precautions for the quantity handled. Eye protection and gloves are recommended.

Accepted in Europe as a food additive (E954, which covers saccharin and its salts) and permitted as a sweetener in foods in the USA. Included in the FDA Inactive Ingredient Database (mainly oral and dental preparations) and in non-parenteral medicines licensed in Europe.

Acesulfame potassium; aspartame; saccharin; saccharin calcium; sodium cyclamate; sucralose.

Because the commercial material contains a variable amount of water of hydration, quantities are often expressed on the anhydrous basis; check the supplier's specification when converting between forms. Its sweetness is perceived quickly but the aftertaste lingers, which is why blends are usually preferred.