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Sodium Stearyl Fumarate or Sodium Octadecyl USP BP Ph Eur FCC Food Grade Supplier Exporter Manufacturers' Representative |
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Sodium Stearyl Fumarate or Sodium Octadecyl
CAS Number: 4070-80-8
Molecular Formula: C22H39NaO4
Molecular Weight: 390.53
Sodium Stearyl Fumarate or Sodium Octadecyl
Sodium stearyl fumarate is a water-soluble lubricant used in the pharmaceutical industry for tableting. Sodium stearyl fumarate is an inert, hydrophilic, tablet lubricant, useful in situations where other lubricating agents fail to provide tablets of adequate stability, hardness, content uniformity, disintegration and dissolution rate.
Specifications of Sodium Stearyl Fumarate USP NF Grade:
DEFINITION
Sodium Stearyl Fumarate contains NLT 99.0% and NMT 101.5% of sodium stearyl fumarate (C22H39NaO4), calculated on the anhydrous basis.
IDENTIFICATION
Infrared Absorption:
Analysis: Perform test on an undried specimen (1 in 300).
Acceptance criteria: Meets the requirements
ASSAY
To pass the test.
Acceptance criteria: 99.0%–101.5% on the anhydrous basis
Limit of Sodium Stearyl Maleate and Stearyl Alcohol: To pass the test.
Acceptance criteria: The intensity of any spot from the Sample solution is not greater than that from the corresponding spot from the Standard monostearyl maleate solution and Standard stearyl alcohol solution (NMT 0.25% sodium stearyl maleate, NMT 0.5% stearyl alcohol).
Lead: NMT 10 ppm.
Water Determination: NMT 5.0%
Fats and fixed Oils, Saponification Value: To pass the test.
Acceptance criteria: 142.2–146.0, calculated on the anhydrous basis.
Specifications of Sodium Stearyl Fumarate FCC Food Grade:
NaOOCCH=HCCOOC18H37
C22H39NaO4 Formula weight 390.54
INS: 1169 CAS: CAS 4070-80-8
DESCRIPTION
Sodium Stearyl Fumarate occurs as a fine, white powder. It is slightly soluble in methanol but is practically insoluble in water.
Function: Dough conditioner.
REQUIREMENTS
Identification: The infrared absorption spectrum of a 1:300 potassium bromide dispersion of the sample exhibits relative maxima at the same wavelengths as those of a similar preparation of USP Sodium Stearyl Fumarate Reference Standard.
Assay: Not less than 99.0% and not more than 101.5% of C22H39NaO4, calculated on the anhydrous basis.
Lead: Not more than 2 mg/kg.
Saponification Value: Between 142.2 and 146.0, calculated on the anhydrous basis.
Sodium Stearyl Maleate: Not more than 0.25%.
Stearyl Alcohol: Not more than 0.5%.
Water: Not more than 5.0%.
We also supply Sodium Stearyl Fumarate BP Ph Eur Grade.
Please visit SDS Safety Data Sheet of Sodium Stearyl Fumarate or Sodium Octadecyl Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org