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Description
Magnesium Stearate meeting BP (British Pharmacopoeia), EP (European Pharmacopoeia), USP (United States Pharmacopeia), and NF (National Formulary) standards is a high-purity, metal-organic salt composed of magnesium and stearic acid
Key Characteristics & Composition
- Chemical Identity: Magnesium octadecanoate (Mg(C₁₈H₃₅O₂)₂, CAS 557-04-0), classified as a metallic soap
. - Appearance: Fine, white, odorless, hydrophobic, and slightly greasy powder
. - Pharmacopeial Requirements (USP-NF / EP / BP): Typically requires 4.0% to 5.5% magnesium content and a specific fatty acid profile (primarily stearic and palmitic acids), strict limits on heavy metals (such as lead under 10 ppm), and low moisture content
. - Source: Can be derived from vegetable oils (such as palm or cottonseed) or animal fats (tallow), as well as synthetic routes
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- Chemical Identity: Magnesium octadecanoate (Mg(C₁₈H₃₅O₂)₂, CAS 557-04-0), classified as a metallic soap
Primary Uses
- Pharmaceutical & Nutraceutical Excipient: Acts as a primary tablet and capsule lubricant, anti-adherent, and flow agent (typically used at 0.2% to 5% concentration) to keep powders from sticking to machinery during high-speed production
. - Food & Cosmetic Additive: Functions as an anti-caking agent, release agent, or texture enhancer in powders, confectionery, and cosmetics.
Safety
- Regulatory Status: Generally recognized as safe (GRAS) and FDA-approved for use in foods and oral medications
. - Digestion: In the body, it breaks down into its natural components—magnesium and stearic acid (a common saturated fatty acid metabolized like other dietary fats)
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