Sodium Stearyl Fumarate
Sodium Stearyl Fumarate Chemical Properties
- storage temp. Inert atmosphere,Room Temperature
- solubility Practically insoluble in water, slightly soluble in methanol, practically insoluble in acetone and in anhydrous ethanol.
- form neat
Sodium Stearyl Fumarate Usage And Synthesis
- DescriptionSodium Stearyl Fumarate (SSF) is used as a lubricant in tableting to reduce the friction between the tablet and the die wall and to prevent adhesion of the material to punches or the die wall in the pharmaceutical industries. It is used also as a lubricant in the manufacturing of capsules and other oral dosage forms. Sodium stearyl fumarate is also used in food production as a dough conditioner, a conditioning agent, and a stabilizing agent.
- Chemical PropertiesWhite or off-white crystalline powder
- Chemical PropertiesSodium stearyl fumarate is a fine, white powder with agglomerates of flat, circular-shaped particles.
- UsesSodium Stearyl Fumarate is a dough conditioner and conditioning agent that is a white powder practically insoluble in water. It is used as a dough conditioner in yeast-raised baked goods. It is used as a conditioning agent in dehydrated potatoes. It also functions as a maturing and bleaching agent.
- Usescationic transfection agent, bile acid sequestrant, vaccine adjuvant, protein stabilizer
- Production MethodsStearyl alcohol is reacted with maleic anhydride. The product of this reaction then undergoes an isomerization step followed by salt formation to produce sodium stearyl fumarate.
- Pharmaceutical ApplicationsSodium stearyl fumarate is used as a lubricant in capsule and tablet formulations at 0.5–2.0% w/w concentration. It is also used in certain food applications.
- SafetySodium stearyl fumarate is used in oral pharmaceutical formulations
and is generally regarded as a nontoxic and nonirritant
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.
- storageAt ambient temperature, sodium stearyl fumarate is stable for up to
3 years when stored in amber glass bottles with polyethylene screw
The bulk material should be stored in a well-closed container in a cool, dry place.
- IncompatibilitiesSodium stearyl fumarate is reported to be incompatible with chlorhexidine acetate.
- Regulatory StatusGRAS listed. Permitted by the FDA for direct addition to food for human consumption as a conditioning or stabilizing agent in various bakery products, flour-thickened foods, dehydrated potatoes, and processed cereals up to 0.2–1.0% by weight of the food. Included in nonparenteral medicines licensed in the UK. Included in the FDA Inactive Ingredients Database (oral capsules and tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients.
- References Arne W. Hölzer and John Sjögren, Evaluation of sodium stearyl fumarate as a tablet lubricant, International Journal of Pharmaceutics, 1979, vol. 2, 145-153
 Holger Zorn and Peter Czermak, Biotechnology of Food and Feed Additives, 2014
- 2-CHLOROMETHYL-5-TRIFLUOROMETHYL-[1,3,4]OXADIAZOLE Sitagliptin Impurity 34 2,4,5-TRIFLUOROBENZYL CHLORIDE (R)-methyl 3-acetamido-4-(2,4,5-trifluorophenyl)butanoate Benzenebutanoicacid,b-[[(1,1-diMethylethoxy)carbonyl]aMino]-2,4,5-trifluoro-,Methylester,(bR)- Sitagliptin 3-OXO-4-(2,4,5-TRIFLUORO-PHENYL)-BUTYRIC ACID METHYL ESTER Stearyl glycyrrhetinate Monosodium fumarate ethyl 3-oxo-4-(2,4,5-trifluorophenyl)butanoate Methyl 3-aMino-4-(2,4,5-trifluorophenyl)butanoate Sitagliptin impurity 5 Sitagliptin Impurity 77 Sitagliptin Impurity 46 Sitagliptin Impurity 28 2-Pentafluorophenyl-malonic acid diethyl ester 2,2,2-TRIFLUORO-N'-(TRIFLUOROACETYL)ACETOHYDRAZIDE (S)-Sitagliptin Phosphate
Sodium Stearyl FumarateSupplierMore
- Company Name:Hangzhou Read Chemical Co., Ltd Gold
- Company Name:Huainan Kedi Chemical Factory Gold
- Company Name:Shandong Huishengtang Biological Medicine Co., Ltd. Gold
- Company Name:Suzhou Southeast Pharmaceutical Co., Ltd. Gold
- Company Name:J & K SCIENTIFIC LTD.
- Tel:400-666-7788 010-82848833-