International Numbering System (INS) for Food Additives: 954
Food additives Europe numbers: E954
Functional Category
Sweetening agent.
Applications in Pharmaceutical Formulation
Saccharin sodium is an intense sweetening agent used in beverages, food products, table-top sweeteners,(1) and pharmaceutical formulations such as tablets, powders, medicated confectionery, gels, suspensions, liquids, and mouthwashes;(2) see Table I. It is also used in vitamin preparations. Saccharin sodium is considerably more soluble in water than saccharin, and is more frequently used in pharmaceutical formulations. Its sweetening power is approximately 300–600 times that of sucrose. Saccharin sodium enhances flavor systems and may be used to mask some unpleasant taste characteristics. Injection of saccharin sodium has been used to measure the armto-tongue circulation time.
Description
Saccharin sodium occurs as a white, odorless or faintly aromatic, efflorescent, crystalline powder. It has an intensely sweet taste, with a metallic or bitter aftertaste that at normal levels of use can be detected by approximately 25% of the population. The aftertaste can be masked by blending saccharin sodium with other sweeteners. Saccharin sodium can contain variable amounts of water.
Stability and Storage Conditions
Saccharin sodium is stable under the normal range of conditions employed in formulations. Only when it is exposed to a high temperature (1258C) at a low pH (pH 2) for over 1 hour does significant decomposition occur. The 84% grade is the most stable form of saccharin sodium since the 76% form will dry further under ambient conditions. Solutions for injection can be sterilized by autoclave. Saccharin sodium should be stored in a well-closed container in a dry place.
Incompatibilities
Saccharin sodium does not undergo Maillard browning.
Safety
There has been considerable controversy concerning the safety of saccharin and saccharin sodium in recent years; however, it is now generally regarded as a safe, intense sweetener. See Saccharin for further information. The WHO has set a temporary acceptable daily intake of up to 2.5 mg/kg body-weight for saccharin, including its salts.(3) In the UK, the Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment (COT) has set an acceptable daily intake for saccharin and its salts (expressed as saccharin sodium) at up to 5 mg/kg body-weight.(4) LD50 (mouse, oral): 17.5 g/kg(5) LD50 (rat, IP): 7.1 g/kg LD50 (rat, oral): 14.2 g/kg