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Sodium Stearyl Fumarate

Product Name
Sodium Stearyl Fumarate
CAS No.
4070-80-8
Chemical Name
Sodium Stearyl Fumarate
Synonyms
Pruv;Sodium octadecyl;Sodium octadecyl fum;Sod. Stearyl fumarate;Sodium stearyl fumarat;Sodium steryl fumarate;SODIUM STEARYL FUMARATE;Sodium stearyi fumarate;SodiuM Srearyl FuMarate;Sitagliptin Impurity 93
CBNumber
CB8725343
Molecular Formula
C22H41NaO4
Formula Weight
392.56
MOL File
4070-80-8.mol
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Sodium Stearyl Fumarate Property

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.
form 
Solid
color 
White to Off-White
InChIKey
GKCVIRALYIXVLE-RZLHGTIFSA-M
LogP
8.789 (est)
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Safety

Hazard Codes 
Xi
Risk Statements 
36/38
Safety Statements 
26
WGK Germany 
3
HS Code 
2917191600
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Hazard and Precautionary Statements (GHS)

Symbol(GHS)
Signal word
Warning
Hazard statements

H302Harmful if swallowed

H315Causes skin irritation

H319Causes serious eye irritation

H335May cause respiratory irritation

Precautionary statements

P261Avoid breathing dust/fume/gas/mist/vapours/spray.

P280Wear protective gloves/protective clothing/eye protection/face protection.

P301+P312IF SWALLOWED: call a POISON CENTER or doctor/physician IF you feel unwell.

P302+P352IF ON SKIN: wash with plenty of soap and water.

P305+P351+P338IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continuerinsing.

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N-Bromosuccinimide Price

Sigma-Aldrich
Product number
PHR1444
Product name
Sodium stearyl fumarate
Packaging
1g
Price
$101
Updated
2024/03/01
Sigma-Aldrich
Product number
1614705
Product name
Sodium stearyl fumarate
Packaging
200mg
Price
$474
Updated
2024/03/01
TCI Chemical
Product number
S0879
Product name
Sodium Stearyl Fumarate
Purity
>98.0%(T)
Packaging
25g
Price
$71
Updated
2024/03/01
TCI Chemical
Product number
S0879
Product name
Sodium Stearyl Fumarate
Purity
>98.0%(T)
Packaging
100g
Price
$221
Updated
2024/03/01
Sigma-Aldrich
Product number
S0808000
Product name
Sodium stearyl fumarate
Purity
European Pharmacopoeia (EP) Reference Standard
Packaging
s0808000
Price
$220
Updated
2024/03/01
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Sodium Stearyl Fumarate Chemical Properties,Usage,Production

Description

Sodium 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 Properties

White or off-white crystalline powder

Chemical Properties

Sodium stearyl fumarate is a fine, white powder with agglomerates of flat, circular-shaped particles.

Uses

Sodium 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.

Production Methods

Stearyl 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.

General Description

Sodium Stearyl Fumarate is commonly used in tablet formulations as a lubricant and anti-adherent to improve  powder flowability, reduce tablet sticking, and enhance the dissolution properties of the tablet.

Pharmaceutical Applications

Sodium 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.

Safety

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.

storage

At ambient temperature, sodium stearyl fumarate is stable for up to 3 years when stored in amber glass bottles with polyethylene screw caps.
The bulk material should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Sodium stearyl fumarate is reported to be incompatible with chlorhexidine acetate.

Regulatory Status

GRAS 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

[1] Arne W. Hölzer and John Sjögren, Evaluation of sodium stearyl fumarate as a tablet lubricant, International Journal of Pharmaceutics, 1979, vol. 2, 145-153
[2] Holger Zorn and Peter Czermak, Biotechnology of Food and Feed Additives, 2014
[3] https://www.fda.gov

Sodium Stearyl Fumarate Preparation Products And Raw materials

Raw materials

Preparation Products

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Sodium Stearyl Fumarate Suppliers

LGM Pharma
Tel
1-(800)-881-8210
Fax
615-250-9817
Email
inquiries@lgmpharma.com
Country
United States
ProdList
2123
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Alfa Chemistry
Tel
1-516-6625404
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1-516-927-0118
Email
support@alfa-chemistry.com
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United States
ProdList
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Standardpharm Co. Ltd.
Tel
86-714-3992388
Email
overseasales1@yongstandards.com
Country
United States
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Protheragen-ING
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+16313385890
Email
info@protheragen-ing.com
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United States
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sales@aladdinsci.com
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SPI PHARMA
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STAUBER (now a part of Hawkins, Inc.)
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VWR International, LLC.
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TCI America, Inc. (part of Tokyo Chemical Industry)
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United States Biological
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TCI America
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Combi-Blocks Inc.
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View Lastest Price from Sodium Stearyl Fumarate manufacturers

Hebei Zhuanglai Chemical Trading Co.,Ltd
Product
Sodium monooctadecyl 2-butenedioate, (E)- 4070-80-8
Price
US $70.00/kg
Min. Order
1kg
Purity
99
Supply Ability
5000
Release date
2024-05-28
Hebei Zhuanglai Chemical Trading Co.,Ltd
Product
Sodium octadecyl fumarate 4070-80-8
Price
US $70.00/kg
Min. Order
1kg
Purity
99
Supply Ability
5000
Release date
2024-05-29
Hebei Zhuanglai Chemical Trading Co.,Ltd
Product
Sodium Stearyl Fumarate 4070-80-8
Price
US $10.00/kg
Min. Order
1kg
Purity
99%
Supply Ability
20ton
Release date
2024-05-06

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