Magnesium Stearate BP

Abstract:
Magnesium stearate is the chemical compound with the formula Mg(C18H35O2)2. It is a soap, consisting of salt containing two equivalents of stearate (the anion of stearic acid) and one magnesium cation (Mg2+). Magnesium stearate is a white, water-insoluble powder.

 

Uses/Applications:

It is used as a release agent and as a component or lubricant in the production of pharmaceuticals and cosmetics. Magnesium stearate is often used as an anti-adherent in the manufacture of medical tablets, capsules and powders. In the creation of pressed candies, magnesium stearate acts as a release agent and it is used to bind sugar in hard candies such as mints.

 

Identity:
Molecular Formula: Mg(C18H35O2)2.
Molecular Weight: 591.27 g/mol
CAS No.: 557-04-0

 

Test Specification
Characters It occurs as a white, very fine, light powder, greasy to touch
Identification

Test A

Test B

Test C

Test D

 

(a)Freezing point: Minimum 530C

(b)Acid Value: 195 to 210

(c)Specified test

(d) Specified Test. A white crystalline precipitate is formed

Solubility Practically insoluble in water and in anhydrous ethanol
Acidity or alkalinity Specified test
Chlorides Not more than 0.1%
Sulfates Not more than 1.0%
Cadmium Not more than 3 ppm
Lead Not more than 10 ppm
Nickel Not more than 5ppm
Loss on drying Not more than 6.0%
Assay:

(a) Stearic  Acid in Fatty acid fraction

(b)Magnesium

(c)Stearic acid + palmitic acid

 

(a)Not less than 40.0%

 

(b)Not less than 4.0% and not more than 5.0% (dried substances)

(c)Not less than 90%

 

Shelf life, Storage and Packing

It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.

 

Other
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.

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