 |
Magnesium Stearate USP NF FCC Food Grade Supplier Exporter Manufacturers' Representative |
Email: info@ammol.org |
Call Toll Free +1-855-552-6665 |
Magnesium Stearate
CAS Number: 557-04-0
Molecular Formula: (C17H35COO)2Mg
Molecular Weight: 591.25
Magnesium Stearate
Magnesium Stearate USP NF Grade Specifications
Octadecanoic acid, magnesium salt. ----- 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.
Acidity or alkalinity: Transfer 1.0 g Magnesium stearate to a 100-mL beaker, add 20 mL of carbon dioxide-free water, boil on a steam bath for 1 minute with continuous shaking, cool, and filter. Add 0.05 mL of bromothymol blue TS to 10 mL of the filtrate: not more than 0.05 mL of 0.1 N hydrochloric acid or 0.1 N sodium hydroxide is required to change the color of the indicator.
Loss on drying: Dry it at 105 to constant weight: it loses not more than 6.0% of its weight.
Specific surface area: [NOTE—In cases where there are no functionality-related concerns regarding the specific surface area of this article, this test may be omitted.] Where the labeling states the specific surface area, determine the specific surface area value as directed in the chapter in the P/P0 range of 0.05 to 0.15, and using out gassing conditions of 2 hours at 40 . If the plot deviates from linearity for P/P0 values of 0.05 to 0.15, then a suitable range of P/P0 values should be validated for linearity. In this case, it is necessary to state the range of validated P/P0 values, the increment of the P/P0 values, and the out gassing conditions employed.
Limit of chloride: A 10.0-mL portion of the aqueous solution obtained in Identification test A shows no more chloride than corresponds to 1.4 mL of 0.020 N hydrochloric acid (0.1%).
Limit of sulfate: A 3.0 mL portion of the aqueous solution obtained in Identification test A shows no more sulfate than corresponds to 3.0 mL of 0.020 N sulfuric acid (1.0%).
Lead: Ignite 0.50 g Magnesium stearate in a silica crucible in a muffle furnace at 475 to 500 for 15 to 20 minutes. Cool, add 3 drops of nitric acid, evaporate over a low flame to dryness, and again ignite at 475 to 500 for 30 minutes. Dissolve the residue in 1 mL of a mixture of equal parts by volume of nitric acid and water, and wash into a separator with several successive portions of water. Add 3 mL of Ammonium Citrate Solution and 0.5 mL of Hydroxylamine Hydrochloride Solution, and render alkaline to phenol red TS with ammonium hydroxide. Add 10 mL of Potassium Cyanide Solution. Immediately extract the solution with successive 5-mL portions of Dithizone Extraction Solution, draining off each extract into another separator, until the last portion of dithizone solution retains its green color. Shake the combined extracts for 30 seconds with 20 mL of 0.2 N nitric acid, and discard the chloroform layer. Add to the acid solution 4.0 mL of Ammonia-Cyanide Solution and 2 drops of Hydroxylamine Hydrochloride Solution. Add 10.0 mL of Standard Dithizone Solution, and shake the mixture for 30 seconds. Pass the chloroform layer through an acid-washed filter paper into a color-comparison tube, and compare the color with that of a standard solution prepared as follows. To 20 mL of 0.2 N nitric acid add 5 ?g of lead, 4 mL of Ammonia-Cyanide Solution, and 2 drops of Hydroxylamine Hydrochloride Solution, and shake with 10.0 mL of Standard Dithizone Solution for 30 seconds. Pass through an acid-washed filter paper into a color comparison tube. The color of the sample solution does not exceed that of the control (0.001%).
Relative content of stearic acid and palmitic acid: The stearate peak comprises not less than 40%; and the sum of the stearate and palmitate peaks is not less than 90% of the total area of all fatty acid ester peaks in the chromatogram.
Magnesium Stearate FCC Food Grade Specifications
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 105C for 20 min. The solidification point of the fatty acids so obtained is not below 54C
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%.
We also supply Magnesium Stearate of BP Ph Eur Grade.
Please visit SDS Safety Data Sheet of Magnesium Stearate 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