Magnesium Stearate
Item specifics
- color
- light white powder
- pharmaceutical material
- lubricant
Review
Description
Magnesium Stearate
Product: Magnesium Stearate Molecular Formula:C36H70MgO4
Property: It is white, greasy powder, hardly disolved in water, ethanol, or acther, soluble in hot water and warm ethanol. It conforms to the standard of CP 2000 Edition, BP 2005, and USP29.
Specifications:
Appearance | White fine powder |
Assay(Mg)% | 4.0-5.0 |
Chloride content % | 0.25Max |
Sulfates content % | 0.5max |
Loss of drying % | 6.0max |
Heavy metals % | 0.001max |
Arsenic mg/kg | 3.0max |
Stearic acid and palmitic acid % | 90min |
Stearic acid % | 40min |
Organic volatile impurited | Conform |
Applications:
Used as lubricant, glidante and anti-adhereute, in the tablet and capsule.
Packing: 10kgs/bag or 10kgs/barrel
CERTIFICATE OF ANALYSIS
Name: Magnesium Stearate USP35-NF30 Batch Number: 20170108
Batch Size: 9000kg Packing Size: 20kg/bag
Certificate No.:20170108 MFG Date: January 8, 2017
Date of Release: January 10, 2017 Expiry Date: January 7th, 2019
ANALYSIS AS PER USP35-NF30.
Items of Test | Standard | Result of Test |
Appearance | A very fine, light white powder, odorless | Conforms |
Identification A TO B | Conforms | Conforms |
Acidity and Alkalinity | Conforms | Conforms |
Chlorides | ≤0.1% | <0.1% |
Sulphates | ≤1.0% | <0.5% |
Heavy metal(lead) | ≤10ppm | 0.12ppm |
Cadmium | ≤3ppm | 0,09ppm |
Nickel | ≤5ppm | 0.09ppm |
Loss on drying | ≤6.0% | 4.5% |
Magnesium(Mg) | 4.0%-5.0% | 4.7% |
stearic acid and palmitic acid | ≥90% | 99.25% |
Stearate acid | ≥40% | 41.0% |
Total microbial count | ≤1000CFU/GRAM | Conforms |
Total mold and yeast | ≤100CFU/GRAM | Conforms |
Escherichia coli | Absent | Absent |
Salmonella species | Absent | Absent |
Conclusion: It meets the standard USP35-NF30.
