Excepients

 
   
Magnesium Stearate

 

 

 

 

 

 

NAME Magnesium Stearate
FORMULA Mg(C18 H35 O2)2
Molecular Wt. 591.27
CAS No. 557-04-0


Magnesium stearate, also called octadecanoic acid, magnesium salt, is a white substance which is solid at room temperature. It has the chemical formula Mg(C18H35O2)2. It is a salt containing two equivalents of stearate (the anion of stearic acid) and one magnesium cation (Mg2+). Magnesium stearate melts at about 120 °C, is not soluble in water, and is generally considered safe for human consumption at levels below 2500 mg/kg per day. In 1979, the FDA's Subcommittee on GRAS (generally recognized as safe) Substances (SCOGS) reported, "There is no evidence in the available information on ... magnesium stearate ... that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current and in the manner now practiced, or which might reasonably."

Application
Magnesium stearate is often used as a diluent in the manufacture of medical tablets, capsules and powders. In this regard, the substance is also useful, because it has lubricating properties, preventing ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets; magnesium stearate is the most commonly used lubricant for tablets. Studies have shown that magnesium stearate may affect the release time of the active ingredients in tablets, etc., but not that it reduces the overall bioavailability of those ingredients. As a food additive or pharmaceutical excipient,
its E number is E470b.

Magnesium stearate is also used to bind sugar in hard candies and is a common ingredient in baby formulas. In pure powder form, the substance can be a dust explosion hazard, although this issue is effectively insignificant beyond the manufacturing plants using it.

Magnesium stearate is manufactured from both animal and vegetable oils. Some nutritional supplements specify that the magnesium stearate used is sourced from vegetables.

Magnesium stearate is a major component of "bathtub rings." When produced by soap and hard water, magnesium stearate and calcium stearate both form a white solid insoluble in water, and are collectively known as "soap scum."

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