Magnesium Stearate Pure & BP Ph Eur USP NF FCC Food Grade Suppliers Exporters, CAS 557-04-0 |
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MSDS of Magnesium Stearate BP Ph Eur USP NF FCC Food grade Manufacturers
Magnesium Stearate
Pure
Also IP BP Ph. Eur. USP NF Reagent FCC Food Grades
Specifications of Magnesium Stearate BP British Pharmacopoeia Ph Eur
Magnesium stearate BP Ph Eur
Action and use
Excipient
DEFINITION
Magnesium stearate is a mixture of magnesium salts of different fatty acids consisting mainly of stearic (octadecanoic) acid [(C17H35COO)2Mg] and palmitic (hexadecanoic) acid [(C15H31COO)2 Mg] with minor proportions of other fatty acids. It contains not less than 4.0 per cent and not more than 5.0 per cent of Mg, calculated with reference to the dried substance. The fatty acid fraction contains not less than 40.0 per cent of stearic acid and the sum of stearic acid and palmitic acid is not less than 90.0 per cent.
CHARACTERS
A white or almost white, very fine, light powder, greasy to the touch, practically insoluble in water and in ethanol.
IDENTIFICATION
First identification C, D.
Second identification A, B, D.
A. The residue obtained in the preparation of solution S (see Tests) has a freezing point not lower than 53C.
B. The acid value of the fatty acids (2.5.1) is 195 to 210, determined on 0.200 g of the residue obtained in the preparation of solution S dissolved in 25 ml of the prescribed mixture of solvents.
C. Examine the chromatograms obtained in the test for fatty acid composition. The retention times of the principal peaks in the chromatogram obtained with the test solution are approximately the same as those of the principal peaks in the chromatogram obtained with the reference solution.
D. 1 ml of solution S gives the reaction of magnesium.
TESTS
Meets all the tests for Specifications of Magnesium Stearate BP Ph Eur mongograph.
Magnesium Stearate USP NF
Magnesium Stearate
Octadecanoic acid, magnesium salt.
Magnesium stearate CAS 557-04-0
Magnesium Stearate is a compound of magnesium with a mixture of solid organic acids, and consists chiefly of variable proportions of magnesium stearate and magnesium palmitate. The fatty acids are derived from edible sources. It contains not less than 4.0 percent and not more than 5.0 percent of Mg, calculated on the dried basis.
Identification—
A: Mix 5.0 g Magnesium stearate with 50 mL of peroxide-free ether, 20 mL of diluted nitric acid, and 20 mL of water in a round-bottom flask. Connect the flask to a reflux condenser, and reflux until dissolution is complete. Allow to cool, and transfer the contents of the flask to a separator. Shake, allow the layers to separate, and transfer the aqueous layer to a flask. Extract the ether layer with two 4-mL portions of water, and add these aqueous extracts to the main aqueous extract. Wash the aqueous extract with 15 mL of peroxide-free ether, transfer the aqueous extract to a 50-mL volumetric flask, dilute with water to volume, and mix. Retain this solution for the Limit of chloride and Limit of sulfate tests. This solution responds to the test for Magnesium.
B: The retention times of the peaks corresponding to stearic acid and palmitic acid in the chromatogram of the Test solution correspond to those in the chromatogram of the System suitability solution, as obtained in the Relative content of stearic acid and palmitic acid test.
Microbial limits— The total aerobic microbial count does not exceed 1000 cfu per g, the total combined molds and yeasts count does not exceed 500 cfu per g, and it meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
TESTS
Meets all the tests for Specifications of Magnesium Stearate USP NF mongograph.
Magnesium Stearate FCC Food Grade
Magnesium stearate FCC
Magnesium stearate CAS 557-04-0
DESCRIPTION
Magnesium Stearate occurs as a fine, white, bulky powder that is unctuous and free from grittiness. It is a compound of magnesium with a mixture of solid organic acids obtained from edible sources and consists chiefly of variable proportions of Magnesium Stearate and magnesium palmitate. It is insoluble in water, in alcohol, and in ether.
Function: Ant caking agent; binder; emulsifier.
REQUIREMENTS
Identification:
A. Heat 1 g of Magnesium stearate with a mixture of 25 mL of water and 5 mL of hydrochloric acid. Liberated fatty acids float as an oily layer on the surface of the liquid. The water layer gives positive tests for Magnesium.
B. Mix 25 g of Magnesium stearate with 200 mL of hot water, then add 60 mL of 2 N sulfuric acid, and while stirring frequently, heat the mixture until the fatty acids separate cleanly as a transparent layer. Wash the fatty acids with boiling water until they are free from sulfate, collect them in a small beaker, and warm them on a steam bath until the water has separated and the fatty acids are clear. Allow the acids to cool, pour off the water layer, then melt the acids, filter into a dry beaker, and dry at 105° for 20 min. The solidification point of the fatty acids so obtained is not below 54°
Assay: Not less than 6.8% and not more than 8.3% of MgO.
Lead: Not more than 5 mg/kg.
Loss on Drying: Not more than 4.0%.
Magnesium Stearate BP Ph Eur USP NF FCC Food grade Manufacturers at:
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