Products – Anmol Chemicals Private Limited

Magnesium Stearate USP

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 very fine, light, white powder, slippery to touch
Identification

Test(A)

Test (B)

 

(A)The solution responds to the test for magnesium

(B) Specified test

Solubility It is insoluble in water, in alcohol, and in ether.
Acidity or alkalinity Specified Test
Loss on drying Not more than 6.0%
Specific surface area Specified Test
Chloride Not more than 0.1%
Sulfate Not more than 1.0%
Limit of Cadmium Not more than 3 ppm
Limit of Lead Not more than 10 ppm
Limit of Nickel Not more than 5 ppm
Relative content of stearic acid and palmitic acid Specified Test
Residual solvents Meets the requirements
Assay Not less than 4.0% and not more than 5.0% of on dried basis

 

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)