Pharmaceutical Excipient Grade Magnesium Stearate CAS No.557-04-0
- HSYC
- CHINA
- 10-20 DAYS
- 100 TONS/MONTH
IDENTITY
Chemical names: Magnesium stearate
CAS number: 557-04-0
Molecular formula: [CH3(CH2)16COO]2Mg
Appearance: Free flow white powder
Purity: 99% min
Pharmaceutical Excipient Grade Magnesium Stearate CAS No.557-04-0
Pharma Grade Magnesium Stearate is a mixture of magnesium salts of different fatty acids consisting mainly of stearic acid [(C17H35COO)2Mg;Mr591.3] and palmitic acid [(C15H31COO)2 Mg;Mr535.1] 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%.
Magnesium Stearate Pharma Grade is a white, very fine light powder, greasy to the touch, practically insoluble in water and in ethanol.
SPECIFICATION
Item | Unit | Value |
Fatty acid composition | / | Stearic acid 40%min Sum of stearic acid and palmitic acid 90%min |
Assay | % | Mg: 4.0~5.0 |
Chlorides | % | 0.1 max |
Sulphates | % | 0.6 max |
Loss on drying | % | 5.0 max |
Iron salt | % | 0.01 max |
Heavy metals | ppm | 10 max |
Acidity or alkalinity | / | + |
Cadmium | ppm | 3 max |
Lead | ppm | 10 max |
Nickel | ppm | 5 max |
Microbial limit | / | Aerobic microbial count 1000cfu/g max Total yeasts count 100cfu/g max |
Particle size(Passing 45um) | % | 99.0 min |
Quality standard | ChP2015, BP2011, USP34/NF29 | |
APPLICATION
Medications.
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.
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%.
PACKAGE AND STORAGE
Shelf life: 3 years.
