Sodium Stearyl Fumarate manufacturers and suppliers

Sodium Stearyl Fumarate suppliers

Properties

Melting point:: >196°C (dec.)

storage temp.: Inert atmosphere,Room Temperature

solubility: Practically insoluble in water, slightly soluble in methanol, practically insoluble in acetone and in anhydrous ethanol.

color: White to Off-White

InChIKey: GKCVIRALYIXVLE-RZLHGTIFSA-M

LogP: 8.789 (est)

Safety Information

Symbol(GHS): GHS07

Signal word: Warning

Hazard statements: H302-H315-H319-H335

Precautionary statements: P261-P280-P301+P312-P302+P352-P305+P351+P338

Hazard Codes: Xi

Risk Statements: 36/38

Safety Statements: 26

WGK Germany: 3

HS Code: 2917191600

Use

Sodium stearyl fumarate is used in oral pharmaceutical formulations and is generally regarded as a nontoxic and nonirritant material. Metabolic studies of sodium stearyl fumarate in the rat and dog indicated that approximately 80% was absorbed and 35% was rapidly metabolized. The fraction absorbed was hydrolyzed to stearyl alcohol and fumaric acid, with the stearyl alcohol further oxidized to stearic acid. In the dog, sodium stearyl fumarate that was not absorbed was excreted unchanged in the feces within 24 hours. Stearyl alcohol and stearic acid are naturally occurring constituents in various food products, while fumaric acid is a normal constituent of body tissue. Stearates and stearyl citrate have been reviewed by the WHO and an acceptable daily intake for stearyl citrate has been set at up to 50 mg/kg body-weight. The establishment of an acceptable daily intake for stearates and fumaric acid was thought unnecessary. Disodium fumarate has been reported to have a toxicity not greatly exceeding that of sodium chloride.

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