Global Calcium is one of the leading manufacturers and exporters of
Magnesium Stearate CAS no. 557-04-0, Mineral Actives
. We support the customers with exhaustive documentation. As a USDMF & EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979.
As manufacturer of Magnesium Stearate we hereby state the following facts about the drug:
Magnesium stearate is the magnesium salt of the fatty acid, stearic acid. It is relatively inexpensive, chemically stable, has a high melting point and lubrication property.
Commercially available magnesium stearates are generally a mixture of crystalline forms (anhydrate, monohydrate, dihydrate, and trihydrate). The crystal structures identified for the magnesium stearate hydrates include the plate-shaped dihydrate and needle-shaped monohydrate and trihydrate forms.
Applications and other uses:
- Magnesium stearate has been widely used for many decades in the food industry as an emulsifier, binder, and thickener, as well as an anticaking, lubricant, release, and antifoaming agent
- It is present in many food supplements, confectionery, chewing gum, herbs and spices, and baking ingredients
- Magnesium stearate is also commonly used as an inactive ingredient in the production of pharmaceutical tablets, capsules, and powders
- Magnesium stearate is permitted for use in the European Union and other countries including China, Japan, Australia, and New Zealand, and was granted generally recognized as safe (GRAS) status in the United States
- There is a lack of data available related to the genotoxic potential of magnesium stearate. For the safety assessment of food ingredients, the U.S. Food and Drug Administration (FDA) recommends a bacterial reverse mutation test, an in vitro test for chromosomal damage or gene mutation in mammalian cells, as well as an in vivo test for chromosomal damage using mammalian hematopoietic cells, such as the rodent erythrocyte micronucleus assay which has proven utility for predicting carcinogens
Global Calcium is a leading manufacturer of this drug. We manufacture this pharmaceutical drug and make it available to domestic and overseas market