S96
Sodium stearyl fumarate S96®
Chemical description: Sodium stearyl fumarate is generated from the reaction of stearyl alcohol and maleic anhydride, which is the reaction product isomerized into sodium. The product meets USP/NF, EP, JP pharmacopoeia standards and has DMF, CEP registration number.
Brand: S96®
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General name
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Specification
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Product form
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Characteristics application
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Regulatory comformity
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Sodium stearyl fumarate
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White powder
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Hydrophilic lubricant
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DMF, CEP, GMP
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Characteristics application:
In S96's molecular structure, fumaric acid functional groups are hydrophilic, therefore S96 can decrease the effects on tablet dissolution rate and disintegration time when used as lubricant. There are preparation products partly incompatible with magnesium stearate, for example: Drugs containing carboxyl (Cefaclor), Nifedipine, trandolapril, Ramipril, Clarithromycin, etc.); Drugs containing sulfydryl (Prazol drugs, Mercapto purine); Organic salt drugs(Clopidogrel, Fosinopril) are all rely on S96 to solve the problems.
Sodium stearyl fumarate is now listed in GRAS. FDA permits it being added directly into foods for people as regulator and stabilizer,whose dosage accounts for 0.2-1.0% of the food weight.
Typical dosage: 0.5-2.0%
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