Products – Anmol Chemicals Private Limited

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
We Manufacture Bulk Dugs/API, Excipients, pharmaceuticals (IP/BP/USP/NF/PH. EUR./JP), Speciality Chemicals (Pure/AR/ACS), mineral fortifiers (FCC). our manufacturing facility is GLP, GMP (FDA) approved, ISO 9001, ISO 14001, ISO 22000, FSSC 22000, FSSAI, kosher, halal, COPP and WHO-GMP certified.

Good Manufacturing Practice Certified by World Health Organization (WHO-GMP)
Written Confirmation Certification (WC)
Good Manufacturing Practice (EXCiPACT cGMP)
Good Manufacturing Practice (cGMP)
Good Laboratory Practice (GLP)