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)