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
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.
