Product
Magnesium Stearate Pharma Grade
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DESCRIPTION
Product name: Magnesium Stearate
Other names: Magnesium octadecanoate，Stearate Magnesium
Cas No.: 557-04-0
Chemical formula: [CH3(CH2)16COO]2Mg or Mg(C17H34COO)2
Other names: Octadecanoic Acid, Stearic Acid Magnesium Salt
Ingredients: Pharma grade Magnesium Stearate is a mixture of magnesium salts of different fatty acids consisting mainly of stearic acid [(C17H35COO)2Mg] and palmitic acid [(C15H31COO)2 Mg] with minor proportions of other fatty acids. The fatty acid fraction contains not less than 40.0% of stearic acid and the sum of stearic acid and palmitic acid is not less than 90.0%.
Characters: pharm grade Magnesium Stearate is a white, very fine light powder, greasy to the touch, practically insoluble in water and in ethanol.
SPECIFICATION
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Test items |
Unit |
Specification |
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Fatty acid composition |
/ |
Stearic acid 40%min Sum of stearic acid and palmitic acid 90%min |
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Assay |
% |
Mg: 4.0~5.0 |
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Chlorides |
% |
0.1 max |
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Sulphates |
% |
0.6 max |
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Loss on drying |
% |
5.0 max |
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Iron salt |
% |
0.01 max |
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Heavy metals |
ppm |
10 max |
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Acidity or alkalinity |
/ |
+ |
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Cadmium |
ppm |
3 max |
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Lead |
ppm |
10 max |
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Nickel |
ppm |
5 max |
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Microbial limit |
/ |
Aerobic microbial count 1000cfu/g max Total yeasts count 100cfu/g max
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Particle size(Passing 45um) |
% |
99.0 min |
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Quality standard |
ChP2015, BP2011, USP34/NF29 |
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APPLICATION
Medications. Our pharma grade magnesium stearate is suggested as Excipient and Lubricant in pharmaceutical industry. Its main job is to keep the ingredients in a capsule from sticking together. It also forms a barrier between the medicines and the machines that make them. The powder improves the consistency and quality of the medication capsules.
Cosmetics. In the cosmetic world, our magnesium stearate is a helpful ingredient for many things. It acts as a bulking agent, an anti-caking agent, a colorant, and more.
Safety
Magnesium stearate is generally considered safe for human consumption at levels below 2500 mg/kg per day[12] and is classified in the United States as generally recognized as safe (GRAS). So the recommended dosage is 0.25%~5.0%.
STORAGE
Storage: Magnesium Stearate should be stored in closed package and avoid from moisture and strong sun light.
PACKAGE
Package: Magnesium Stearate package can be customized according to customers’ requirements. If no special instruction, it is packed in 10kg plastic bag or drum.
SHELF LIFE
3 years from the date of manufacturing.
