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Magnesium Stearate Powder Pharmaceutical Excipients Material

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Magnesium Stearate Sepcification

Product Name: Magnesium stearate
Natural/Synthetic: Synthetic
Source of extraction: CP2015
Level: Pharmaceutical grade
Content: 99%
Appearance: white powder
Packing: 10KG/kraft paper bag
Physicochemical properties: white powder
Category: Pharmaceutical Raw Materials
Industry: Pharmaceuticals
Field: Pharmaceutical Excipients
Deferred products: flow aids, anti-adhesives tablets, capsules
Use: pharmaceutical additives, lubricants for tablets and capsules,

 

What is Magnesium stearate?

Magnesium stearate is a white, water-insoluble powder. Its applications exploit its softness, insolubility in many solvents, and low toxicity. It is used as a release agent and as a component or lubricant in the production of pharmaceuticals and cosmetics.

 

Magnesium stearate Certificate of Analysis

Product name Magnesium stearate
CAS No. / Outer Packing 10kg/bag
Production date 2018.04.25 Shelf life 2019.04.24
Standard adopted Enterprise Standard
Items of analysis Specification Results
Character White fine powder, micro special odor; Insoluble in water, ethanol or ether. conforms
Identification 1, should be a positive reaction; 2, the retention time of the two main peaks of the test solution should be consistent with the retention time of the two main peaks of the reference solution. conforms
PH Titrant consumption ≤0.05ml 0.02ml
Chloride(%) ≤0.1% conforms
Sulfate (%) ≤0.6% conforms
Loss on drying ≤5.0% 4.1%
Iron salt (%) ≤0.01% conforms
Cadmium salt (%) ≤0.0003% conforms
Nickel salt (%) ≤0.0005% conforms
Heavy metal ≤15ppm conforms
Stearic acid content (%) ≥40% 43.4%
Stearic acid and palmitic acid relative content (%) ≥90% 99.8%
Aerobic bacteria (cfu/g) ≤1000cfu/g 50cfu/g
Mold and yeast (cfu/g) ≤100cfu/g 30cfu/g
Escherichia coli Do Not Detect Not Detect
Assay Dry products in the range of 4.0%-5.0% by Mg 4.1%
Conclusion Qualified

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