MAGNESIUM STEARATE
MAGNESIUM STEARATE
CAS Number: 557-04-0
EC Number: 209-150-3
Linear Formula: [CH3(CH2)16CO2]2Mg
Molecular Weight: 591.24
E number: E470
Magnesium stearate is the chemical compound with the formula Mg(C18H35O2)2.
Magnesium stearate 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.
Magnesium stearates applications exploit its softness, insolubility in many solvents, and low toxicity.
Magnesium stearate is used as a release agent and as a component or lubricant in the production of pharmaceuticals and cosmetics.
This soft white powder, Magnesium stearate , is used in cosmetics to improve adhesion and slip, and texture.
Generally Magnesium stearate is used in concentrations of 5% – 10% by weight in a loose powder.
Magnesium stearate is an ester of magnesium & stearic acid (vegetable based).
Magnesium stearate is a fine, soft white powder that is used as an additive when making eye shadows.
Magnesium stearate helps micas adhere more uniformly on the skin while giving it a fluffy even consistency.
Magnesium stearate is a perfect example of how selective interpretation of research can lead to errors in clinical application.
Magnesium stearate is an excipient – a substance with minimal biological activity based on the amounts used.
Excipients are added to foods, supplements and drugs to prevent ingredients from clumping or sticking to equipment.
To make a stearate excipient, calcium or magnesium is combined with stearic acid from vegetable oils.
Magnesium stearate is the magnesium salt of the fatty acid, stearic acid.
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.
Magnesium stearate 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.
For food applications, magnesium stearate is typically manufactured by one of two processes.
The direct or fusion process involves direct reaction of fatty acids with a source of magnesium, such as magnesium oxide, to form magnesium salts of the fatty acids.
In the indirect or precipitation process, a sodium soap is produced by reacting fatty acids with sodium hydroxide in water and precipitating the product through addition of magnesium salts to the soap.
The fatty acids used as raw material are derived from edible fats and oils and consist mainly of stearic and palmitic acid.
The final product contains 4.0-5.0% magnesium, on a dried basis, and the fatty acid fraction is composed of ≥90% stearic and palmitic acids, at least 40% of which are stearic acid.
Magnesium stearate is a very fine powder that is greasy to the touch and practically insoluble in water.
Magnesium stearate is a very fine, light white, precipitated or milled, impalpable powder of low bulk density, having a faint odor of stearic acid and a characteristic taste.
Magnesium stearate mainly consists of variable proportions of magnesium stearate and magnesium palmitate obtained from vegetable sources.
Magnesium stearate increases the time it takes for tablets and capsules to dissolve due to the film it forms on capsule or tablet ingredients.
Magnesium stearate coats a good portion of the molecules in a tablet or capsule, requiring digestive enzymes to break down the magnesium stearate coating before being able to access the nutrients it envelops.
WHAT IS MAGNESIUM STEARATE?
Magnesium stearate is created from the reaction of sodium stearate with magnesium sulfate.
Magnesium stearate is a solid substance that comes in powder and granule form.
Magnesium stearate’s white and has a slight fatty acid odor.
USES & APPLICATIONS OF MAGNESIUM STEARATE
The range of magnesium stearate uses and potential applications is broad.
Magnesium stearate can act as an:
Anti-adherent: Magnesium stearate prevents the product from having adhesion properties during production.
Excipient: Magnesium stearate functions as an excipient and is paired with active pharmaceutical ingredients to act as a carrier, making the product easier to manufacture.
Mold-release agent: Magnesium stearate provides the barrier between the mold’s surface and the substrate, so the product comes out of the mold easily.
ABS/SAN internal and external lubricant: The lubricant quality of magnesium stearate helps to reduce friction and adhesion.
De-dusting agent: Magnesium stearate helps remove dust and other fine impurities from products.
Flow enhancer: Magnesium stearate makes products flow easier, becoming smooth and even.
Binder: Magnesium stearate works with other compounds so that together, they are cohesive and stable.
Anti-caking agent: Magnesium stearate prevents lumps from forming in the product.
These qualities make magnesium stearate perfect for use in the manufacture of:
Pharmaceutical tablets: Magnesium stearate acts as a mold release agent and excipient in tableting.
Nutritional supplements: Magnesium stearate is an excipient and mold release agent in the tableting process.
Nutraceuticals: Again, the fact that the ingredient is an excipient and mold release agent in tableting helps in the manufacturing process.
Food and beverage: Magnesium stearate brings flow enhancing, binding and anti-caking qualities to many foods and beverages.
Rubber: Magnesium stearate acts as a de-dusting agent as well as a lubricant in rubber production.
Plastics: Magnesium stearate is a lubricant and de-dusting agent in plastic production.
Personal care and cosmetics: Magnesium stearate may act as a lubricant, increase thickness or prevent emulsions from separating in cosmetic products.
PACKAGING & SHELF LIFE OF MAGNESIUM STEARATE
When Magnesium stearate’s packaged in the best conditions, your supply of magnesium stearate should last Magnesium stearates entire shelf life, which is two years from the date of manufacture.
Magnesium stearate should be kept away from sources of heat, such as sparks, open flames, hot surfaces and direct sunlight.
Magnesium stearate needs to be stored in a dry, cool and well-ventilated location.
When you’re not using Magnesium stearate, keep the container closed.
Make sure Magnesium stearate seals well to prevent moisture from getting inside.
HOW TO DISPOSE OF MAGNESIUM STEARATE
Clean up any spills of magnesium stearate immediately, and wear a dust mask, goggles and gloves.
If you want to use a vacuum, make sure Magnesium stearate’s explosion-proof and has the appropriate filter.
During cleanup, do not mix magnesium stearate with other materials, and keep dust to a minimum.
Dispose of the waste in a safe manner that is in accordance with your local, regional, national and international regulations.
Magnesium stearate Manufacturing
Magnesium stearate is produced by the reaction of sodium stearate with magnesium salts or by treating magnesium oxide with stearic acid.
Some nutritional supplements specify that the sodium stearate used in manufacturing magnesium stearate is produced from vegetable-derived stearic acid.
Magnesium stearate Uses
Magnesium stearate is often used as an anti-adherent in the manufacture of medical tablets, capsules and powders.
In this regard, Magnesium stearate is also useful because Magnesium stearate 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.
However, Magnesium stearate might cause lower wettability and slower disintegration of the tablets and slower and even lower dissolution of the drug.
Magnesium stearate can also be used efficiently in dry coating processes.
In the creation of pressed candies, magnesium stearate acts as a release agent and Magnesium stearate is used to bind sugar in hard candies such as mints.
Magnesium stearate is a common ingredient in baby formulas.
In the EU and EFTA Magnesium stearate is listed as food additive E470b.
Magnesium Stearate is a soft, white powder that is commonly used in mineral make-up, natural deodorant and lotion formulations.
Magnesium stearate provides anti-caking, slip, glide and texture properties to eyeshadows and blush base, as well as a non-slick feel to lotions and creams.
What Is Magnesium Stearate?
Magnesium stearate is a salt that is produced when a magnesium ion bonds with two stearate molecules.
Stearate is just the anion form of stearic acid.
Stearic acid is a long-chain saturated fat that is abundant in beef, cocoa butter, coconut oil, and other natural foods.
As I mentioned in my red meat article, Magnesium stearate’s also the only long-chain saturated fat that scientists and medical practitioners agree doesn’t raise cholesterol levels, and doesn’t increase the risk of heart disease.
Magnesium stearate Uses and Function
Magnesium stearate is most commonly used in supplement manufacturing as a “flow agent,” which helps ensure that the equipment runs smoothly and the ingredients stay blended together in the correct proportions.
Magnesium stearate can also be found in some cosmetics.
Synonyms:
Stearic acid magnesium salt
However, the story is more complicated.
Another paper found that relative to no magnesium stearate, 0.5 percent magnesium stearate did reduce availability of the target molecule, sulphadiazine.
Also, magnesium stearate reacts to active ingredients differently, as do other excipients.
For example, in the case of prednisone, magnesium stearate is preferred over talc, but magnesium stearate cannot be used in the making of ampicillin tablets
Magnesium stearate Occurrence
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.
Magnesium stearate is a fine white powder that sticks to your skin and is greasy to the touch.
Magnesium stearate’s a simple salt made up of two substances, a saturated fat called stearic acid and the mineral magnesium.
Stearic acid can also be found in many foods, such as:
-chicken
-eggs
-cheese
-chocolate
-walnuts
-salmon
-cotton seed oil
-palm oil
-coconut oil
Magnesium stearate is commonly added to many foods, pharmaceuticals, and cosmetics.
In medications and vitamins, Magnesium stearates primary purpose is to act as a lubricant.
magnesium stearate (Mg(C17H34COO)2, CAS Reg. No. 557-04-0) is the magnesium salt of stearic acid.
Magnesium stearate is produced as a white precipitate by the addition of an aqueous solution of magnesium chloride to an aqueous solution of sodium stearate derived from stearic acid.
What does magnesium stearate do?
Magnesium stearate is an additive that’s primarily used in medication capsules.
Magnesium stearate’s considered a “flow agent.”
Magnesium stearate prevents the individual ingredients in a capsule from sticking to each other and the machine that creates the capsules.
Magnesium stearate helps improve the consistency and quality control of medication capsules.
Magnesium stearate’s possible to create medication capsules without magnesium stearate, but Magnesium stearate’s more difficult to guarantee the consistency and quality of those capsules.
Magnesium stearate is used to delay breakdown and absorption of medications, so they’re absorbed in the correct area of the bowel.
Magnesium stearate, a common “inactive” ingredient in many nutritional supplements, has been critiqued by several nutritional supplement companies and physicians online.
Magnesium stearate has been compared to chalk, said to impair absorption of nutrients, to form a harmful “biofilm” in the intestines, and even to suppress immune function.
Since magnesium stearate is an important flow agent that is widely used in the nutritional industry, we felt Magnesium stearate important to carefully examine these claims.
We found that they were all baseless.
Magnesium stearate is the most commonly used metallic salt boundary lubricant containing two equivalents of a fatty acid (usually stearic and palmitic acid) and a charged magnesium.
Magnesium stearate is relatively inexpensive, chemically stable, has a high melting point and lubrication property.
A concentration of 0.25%–5.0% w/w magnesium stearate was used in formulation development.
Magnesium stearates lubricant effect relates to the adherence of the polar moiety on granules/powders, while the lipophilic moiety is oriented outward from the particle’s surface.
Magnesium stearates capacity to form a hydrophobic (waxy) layer around particles leads to reduced water penetration, which compromises the dissolution profile.
Magnesium stearate is a salt that forms when stearate molecules bond with a magnesium ion.
Stearate comes from stearic acid, a long-chain saturated fat found in:
-Beef
-Chicken
-Cocoa butter
-Coconut oil
-Eggs
-Milk and dairy products
-Palm oil
-Salmon
Magnesium stearate is the combination of a Magnesium ion (Mg) and stearic acid.
Magnesium stearate is a white powder.
Magnesium stearate’s used in the manufacture of supplements because Magnesium stearate’s great at keeping the ingredients in the supplements from sticking to the machinery that makes them.
Magnesium stearate basically acts as a lubricant to keep them from clumping.
If magnesium stearate weren’t used, the ingredients put into your multivitamins would end up on the machine parts, not in the capsule or the pill itself.
Magnesium stearate has been considered safe and effective for years, and Magnesium stearate still is.
Most of us don’t remember much of our high school chemistry and really don’t care to.
But, one thing you should be aware of is that although magnesium stearate might sound kind of like stearic acid and the representation of it Mg(C18H35O2)2 is similar to that of stearic acid CH3(CH2)16CO2H that doesn’t mean that chemically the two behave anything alike.
Keep this in mind later in the article.
Many of the articles warning of the use of magnesium stearate mistakenly (or at least wrongly) equate Magnesium stearate with stearic acid.
While magnesium stearate is made from stearic acid, Magnesium stearate’s most definitely not stearic acid any more than water (H2O) is hydrogen (an explosive gas).
Just FYI though, stearic acid is naturally found in many foods (though Magnesium stearate can be created using a chemical process) and is considered a fairly healthy saturated fat.
Magnesium stearate’s found naturally in poultry, fish dairy, grain, cocoa, etc.
One of the most widely used additives in drugs and supplements today is magnesium stearate.
You’ll actually be hard-pressed to find any supplement sold on the market today that doesn’t include Magnesium stearate — whether we’re talking magnesium supplements, digestive enzymes or another supplement of your choice — though you may not see Magnesium stearate named directly.
Commonly referred to by other names, such as “vegetable stearate” or derivatives like “stearic acid,” Magnesium stearate’s virtually everywhere.
In addition to being ubiquitous, magnesium stearate is also one of the most controversial ingredients in the supplement world.
In some ways, Magnesium stearate’s similar to the vitamin B17 controversy, and there’s debate on whether Magnesium stearate’s a poison or a cancer treatment.
Unfortunately for the general public, natural health experts, supplement companies’ researchers and health care practitioners regularly site conflicting evidence to support their personal opinions — and Magnesium stearate’s extremely challenging to get to the facts.
With these kind of debates, Magnesium stearate’s best to take a practical approach and remain leery of siding with extreme perspectives.
The bottom line is this: Like most fillers and bulk additives, magnesium stearate isn’t healthy in high doses, but Magnesium stearate’s not as harmful to consume as some make Magnesium stearate out to be because Magnesium stearate’s typically only available in minuscule doses.
What Is Magnesium Stearate? What Does Magnesium stearate Do?
Magnesium stearate is a magnesium salt of stearic acid.
Essentially, Magnesium stearate’s a compound containing two stearic acids and magnesium.
Stearic acid is a saturated fatty acid found in many foods, including animal and vegetable fats and oils.
Cocoa and flaxseeds are examples of foods that contain substantial amounts of stearic acid.
After magnesium stearate is broken back down into Magnesium stearates component parts in the body, Magnesium stearates fat is essentially the same as that of stearic acid.
Magnesium stearate powder is often used as an additive in dietary supplements, food sources and cosmetics.
Magnesium stearate is a simple salt made of two common nutritional substances, the mineral magnesium and the saturated fat stearic acid.
Magnesium stearate is used as a “flow agent” in many nutritional supplements and pharmaceuticals.
Magnesium stearate contains two molecules of stearic acid and one molecule of magnesium.
The molecule is held together by ionic bonds — the definition of a salt — that break apart easily in acid, the condition found in the human stomach.
Though the name may make Magnesium stearate sound like a synthetic, space-age molecule, both magnesium and stearic acid are abundantly available in many foods in our diet.
In order to really understand magnesium stearate, let’s look at its two components.
Magnesium is an essential mineral, the major mineral most likely to be deficient in the American diet.
I don’t think anyone would argue the safety of magnesium.
Stearic acid is a saturated fatty acid found in many foods including eggs, chicken, grass-fed beef, coconut oil, walnuts, cheese, chocolate, salmon and human breast milk, to name just a few.
Both magnesium and stearic acid are not only safe, they are beneficial to human health.
Magnesium stearate is simply a salt that combines both of these molecules.
Magnesium stearate is the most common ingredient used in forming tablets because Magnesium stearate’s an effective lubricant.
Magnesium stearate’s also used in capsules, powders and in many food products, including a host of confectionary, chewing gum, herbs and spices, and baking ingredients.
Known as a “flow agent,” Magnesium stearate helps speed up the manufacturing process because Magnesium stearate prevents ingredients from sticking to the mechanical equipment.
Just a minuscule amount is required to coat a powder blend of virtually any drug or supplement mixture.
Magnesium stearate also works as an emulsifier, binder, and thickening, anticaking, lubricant, release and antifoaming agent.
Not only is Magnesium stearate fantastic for manufacturing purposes because Magnesium stearate allows for smooth transport on the machines that produce them, but Magnesium stearate makes the pill easier to swallow and move down the gastrointestinal tract.
Magnesium stearate is also a common excipient, which means Magnesium stearate helps enhance the therapeutic effect of the active ingredient of various medications to promote drug absorption and solubility.
Known as safe vehicles for drugs, excipients also help give pills a uniform consistency.
Some claim that Magnesium stearate’s possible to produce a drug or supplement without excipients like magnesium stearate, which begs the question why they’re used when more natural alternatives are available.
But that may not be the case.
CAS Number: 557-04-0
CHEBI: 9254
ChemSpider: 10704
ECHA InfoCard: 100.008.320
E number: E572 (acidity regulators, …)
PubChem CID: 11177
UNII: 70097M6I30
CompTox Dashboard (EPA): DTXSID2027208
What is magnesium stearate?
Magnesium stearate is a combination of stearic acid and the essential mineral magnesium.
Magnesium stearate’s a mixture of pure stearic acid and palmitic acid, where the content of stearic acid is not less than 40.0% and the sum of the two acids is not less than 90.0%.
The British Pharmacopoeia 1993 describes magnesium stearate as consisting mainly of magnesium stearate with variable proportions of magnesium palmitate and magnesium oleate.
Magnesium stearate is a form of chelated pre-acidified magnesium, and just like other chelated minerals (magnesium ascorbate, magnesium citrate, et al) has no inherent negatives based on its being in a stable neutral compound comprised of a mineral and an acid (vegetable-sourced stearic acid from palm oil neutralized with magnesium salts).
Magnesium stearate is a magnesium salt of fatty acids C16 to C18.
NOW uses stearates tested to U.S. Pharmacopeia monograph standards; known as pharmaceutical grade, the highest purity.
Magnesium stearate are non-GMO, free from BSE/TSE, and may be used, if desired, as part of a vegetarian or vegan diet.
What is stearic acid?
Stearic acid (also called Octadecanoic Acid) is one of the most common long-chain fatty acids, found in both natural animal and vegetable fats, known also by Magnesium stearates structural description of being an 18-carbon chain fatty acid (18:0) with a chemical structure of C36H70MgO4.
The Encyclopædia Britannica reports that, “In nature stearic acid occurs primarily as a mixed triglyceride, or fat, with other long-chain acids and as an ester of a fatty alcohol.
Magnesium stearate is much more abundant in animal fat than in vegetable fat; lard and tallow often contain up to 30 percent stearic acid.”
Magnesium stearate is found in many supplements because, during supplement manufacture, it makes Magnesium stearate easier to work with certain ingredients, making them flow more evenly and preventing them, as well as tablets, from sticking to machines during production.
Magnesium stearate is created from reacting stearate (from animal fats — often pig — or plant-based sources such as palm oil, coconut oil, or vegetable oil) with magnesium.
A very small amount is used in supplements, and it typically comprises less than 1% of a total formulation — less than 20 mg.
Magnesium stearate Magnesium stearate’s in a product, you’ll see Magnesium stearate included in the “Other Ingredients” section of supplement labels.
Concerns have been raised that magnesium stearate can have negative effects, such as raising cholesterol levels, suppressing the immune system, creating biofilms in the body, and causing allergic reactions.
As discussed below, there is insufficient scientific evidence to justify these concerns.
Increasing cholesterol levels:
Concern has been raised about the stearic acid in magnesium stearate raising cholesterol levels, as stearic acid is a saturated fat.
This should not be a concern because even normal dietary intake of stearic acid has been shown to have no significant effect on total cholesterol, low-density lipoprotein (LDL) or high-density lipoprotein (HDL) cholesterol levels.
In addition, the amount of stearic acid from magnesium stearate in supplements is very small.
According to USDA nutrition surveys, the average American adult consumes between 5,900 to 8,800 milligrams of stearic acid each day, typically from food sources like beef, poultry, cocoa butter, milk and cheese.
A single chocolate bar contains about 5,000 milligrams of stearic acid.
Meanwhile, the amount of stearic acid in the magnesium stearate in a dietary supplement is generally less than 20 milligrams.
Immune suppression:
Some websites claim that magnesium stearate suppresses the immune system.
This claim seems to be based on on laboratory studies of immune cells from mice showing that that large amounts of stearic acid damaged cell membranes of T-lymphocytes.
However, these laboratory conditions do not represent what happens inside your body when you ingest normal amounts of stearic acid, let alone even smaller amounts of magnesium stearate.
Magnesium stearate is highly unlikely the small amount of magnesium stearate in supplements cause immune suppression, and such an effect has not been reported.
What is Magnesium stearate?
Magnesium stearate (Mg(C18H3502)2 or octadecanoic acid) is a solid, white powder at room temperature.
Magnesium stearate is a FDA-approved inactive ingredient commonly used in the pharmaceutical industry as a diluent for the manufacture of tablet, capsule, and powder dosage forms.
Magnesium stearate is generally recognized as safe by the FDA.
Magnesium stearate exists as a salt form and is useful for it’s lubricating properties for capsules and tablets in industry.
Magnesium stearate is used to help prevent pharmaceutical ingredients from adhering to industry equipment.
Magnesium stearate may be derived from both plant and animal sources.
Magnesium stearate Biofilm production:
One popular website claims that magnesium stearate can promote the growth of bacterial colonies in the gastrointestinal tract and create a “biofilm” preventing the absorption of nutrients.
However, there does not seem to be clinical evidence behind this.
In fact, a laboratory study found stearic acid to inhibit the formation of biofilms.
Magnesium stearate Allergic reaction:
At least one case of allergic reaction to magnesium stearate, which resulted in skin hives, has been reported.
However, this type of reaction seems to be quite rare.
The bottom line:
The amount of magnesium stearate in dietary supplements appears to be quite safe.
Nevertheless, Magnesium stearate is only there to help with manufacturing and Magnesium stearate provides no nutritional advantage.
If you want to avoid Magnesium stearate, look for Magnesium stearate in the “Other Ingredients” section on product labels.
Be aware that magnesium stearate in dietary supplements can come from either vegetable or animal sources.
If you’re looking for a vegetarian source, look for a product that lists “vegetable grade” or “vegetable magnesium stearate.”
Otherwise, Magnesium stearate is most likely sourced from animals.
Analysis of Commercial Magnesium Stearates
Once the sample preparation protocol for magnesium stearate was established, the surface area of four commercially available magnesium stearates was determined.
They were degassed for four hours at 35 °C, then analyzed using two methods of analysis for comparison.
First the more rigorous multipoint analysis was performed and then, for comparison purposes, a single-point analysis of the same samples, under the same testing conditions, was performed.
The middle column labeled BET C is indicative of surface energetics.
Are stearic acid and stearates naturally found in foods?
Yes. Stearic acid (stearate) is a predominant saturated fat in the human diet.
Stearates are nutrients that represent a natural part of every type of fat, whether animal or vegetable, and are typically consumed in amounts of several thousand milligrams per day from common food sources.
A 200-calorie serving of dark chocolate can contain up to 5 grams (5,000 milligrams) of stearates; cocoa butter, coconut oil, beef fat, olive oil, fish, and virtually all fats and oils naturally contain far more stearates than do dietary supplements.
Magnesium stearate or “mag stearate” for short is just a chemical used by most nutritional supplement companies, and Magnesium stearate’s an additive.
Magnesium stearate acts like a lube to run machines faster, so as to increase production and therefore profits.
Magnesium stearate consists of magnesium and stearate which is a saturated fat.
Think of Magnesium stearate like bubble wrap around the ingredients of your supplement.
Are stearates hydrogenated?
No. Stearates can be produced by hydrogenation.
However, there is no need to manufacture stearic acid from cottonseed or other liquid vegetable oils using hydrogenation to artificially saturate the fatty acids.
At Magnesium stearate, we use palm oil that already contains significant amounts of saturated fats providing abundant stearic acid.
We use pure USP-grade magnesium stearate derived from non-hydrogenated, non-GMO, non-irradiated palm oil that contains no trans-fats.
Magnesium stearate, the magnesium salt of stearic acid, is an additive, a flow agent used in pharmaceutical or supplement capsules and tablets.
Stearic acid is saturated fat, while magnesium is an essential mineral.
Both are nutritional substances and are naturally found in a variety of foods.
Far from being harmful, they are in fact beneficial to human health.
Vegetable magnesium stearate is mostly made from palm oil and is a standard for tablets.
However, Magnesium stearate can also be derived from purified cottonseed oil.
The Use of Vegetable Magnesium Stearate in Supplements
Magnesium Stearate in supplement tablets is used as a ‘flow agent’.
Magnesium stearate means that Magnesium stearate prevents different supplement ingredients from sticking to each other and the blending and punching equipment.
Adding a flow agent such as vegetable magnesium stearate is imperative for ensuring a homogenous blend of ingredients and a consistent dosage in each and every capsule or a tablet.
Despite the bad name additives such as vegetable magnesium stearate get in supplements, they are rather necessary and perform different crucial functions in supplement manufacturing.
Not adding magnesium stearate or an alternative can even be detrimental to human health as capsules or tablets may not contain the prescribed dosage consistently.
What happens to stearate in the body?
Stearate is one of the major saturated fatty acids in mammals and is acquired through two pathways:
1) dietary fat absorption and 2) de novo lipogenesis (our bodies make Magnesium stearate from other dietary fats).
Stearic acid may be converted to oleic acid (omega-9 fatty acid) in mammals; which of course does not happen in a test tube study.
Oleic acid is considered a healthy fat, and is a major component of olive oil.
“Upon ingestion, magnesium stearate is dissolved into magnesium ion and stearic and palmitic acids.
Magnesium is absorbed primarily in the small intestine, and to a lesser extent, in the colon.
Magnesium is an essential mineral, serving as a cofactor for hundreds of enzymatic reactions and is essential for the synthesis of carbohydrates, lipids, nucleic acids and proteins, as well as neuromuscular and cardiovascular function.”
Are there any known risks of consuming stearates?
None that are known.
The FDA has affirmed that stearic acid is GRAS (Generally Regarded As Safe) and can be added to foods in accordance with Good Manufacturing Practices (GMP).
NOW is a GMP-certified manufacturer.
Stearic acid magnesium salt, Magnesium octadecanoate
Empirical formula C36H70MgO4
Molar mass (M) 591,25 g/mol
Density (D) 1,03 g/cm³
Melting point (mp) 140 °C
CAS No. [557-04-0]
EG-Nr. 209-150-3
The FDA’s Select Committee on GRAS Substances has also reported on magnesium stearate safety, concluding that, “There is no evidence in the available information on magnesium carbonate, magnesium chloride, magnesium sulfate, magnesium hydroxide, magnesium oxide, 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 be expected in the future.”
The World Health Organization also confirmed the safety of magnesium stearate: “The Committee concluded that there are no differences in the evaluation of the toxicity of magnesium stearate compared with other magnesium salts…”
Stearates are well absorbed (over 90%) and do not coat the G.I. tract.
In fact, they reportedly discourage certain undesirable biofilms.
There is no credible concern that the comparatively tiny amounts in dietary supplements may inhibit absorption of nutrients in vivo (in live people).
A typical supplement with stearate excipients may have less than a tenth of one percent of a typical person’s daily consumption of dietary stearates.
We have extensively investigated the safety of magnesium stearate, which is also considered safe and non-toxic.
Allegations of Magnesium stearates toxicity have been circulating for over 20 years.
We have found the “evidence” to be misleading because it is either largely circumstantial based on test tube studies that don’t accurately represent the data observed in human clinical trials or based on theoretical dangers (such as a type of processing that is not commonly used to make stearic acid from unsaturated fats) that don’t apply to the materials we use.
Either way, the fate of dietary fats in the human body is quite different than what these theories present.
Science assures us that stearic acid is a safe fatty acid found in healthy foods and that magnesium stearate is a safe analog of stearic acid.
NOW uses them only as necessary for the functionality of a particular dietary supplement, in relatively tiny amounts compared to the amount of stearates found in common foods.
What are some of the potential benefits of dietary stearates?
Stearates do not share the cardiovascular risks of other forms of saturated fat.
An American Journal of Nutrition published review of beef’s effect on cholesterol reported that, “Beef products are the most common source of dietary stearic acid in the United States.
Because beef fat is 19% stearic acid, the cholesterol-raising potential of beef is not as great as predicted by its total saturated fatty acid content Data suggest that lean beef is no more hypercholesterolemic than chicken or fish and, therefore, lean beef need not be eliminated from cholesterol-lowering diets.”7
Stearic acid is also one of the main fats in cocoa butter, and this particular fatty acid is considered safer than others present in cocoa butter.
A report from the University of Texas Southwestern Medical Center confirmed this: “Magnesium stearate has been known for some time that cocoa butter, although rich in saturated fatty acids, does not raise total serum cholesterol concentrations as much as expected from its total saturated fatty acid content.
In a recent experiment cocoa butter did not raise LDL cholesterol as much as predicted by its total saturated fatty acid content.”
Researchers at the University of Nebraska noted, “The observation that dietary stearic acid does not raise plasma cholesterol concentration is well documented, although the regulating mechanisms are not completely understood the data suggest that reduced plasma cholesterol concentration in hamsters fed high 18:0 diets may be influenced by reduced cholesterol absorption and increased excretion of endogenous cholesterol.”
Why use Stearic Acid or Magnesium Stearate in some tablets and capsules?
Natural ingredients don’t always smoothly flow through processing equipment, so manufacturers need to utilize excipients like stearates to fill two-piece dry capsules or form tablets.
Stearic acid is a vegetable wax; a waxy oil fraction that acts as a food-grade machine lubricant to help fill capsules efficiently when a dry powdered ingredient (or ingredient mix) is uncooperative; based on issues involving density, stickiness, flowability under pressure, etc.
Magnesium stearate is also used as an ingredient that helps tablets hold together and break apart properly.
Magnesium stearate is the most efficient natural flow agent in this category.
The USDA cites this study regarding the use of magnesium stearate as a functional aid in the manufacture of tablets: “Stearic acid is the predominant fatty acid in triacylglycerols of beef fat and coconut oil (present as the ester).
The free acid is used routinely in many commercial products in addition to foods.
Magnesium stearate is used in polymer formulations as an extrusion aid.
As the magnesium stearate in tablets, Magnesium stearate helps keep the solid ingredients from falling apart in the bottle, and Magnesium stearate also enables the tablet to break apart and release the active ingredient when the tablet is swallowed.”
Chemical formula: Mg(C18H35O2)2
Molar mass: 591.27 g/mol
Appearance: light white powder
Odor: slight
Density: 1.026 g/cm3
Melting point: 88.5 °C (191.3 °F; 361.6 K)
Solubility in water:
0.003 g/100 mL (15 °C)
0.004 g/100 mL (25 °C)
0.008 g/100 mL (50 °C)
Solubility:
negligible in ether and alcohol
slightly soluble in benzene
Experts say stearic acid is the only long-chain saturated fat that does not raise cholesterol levels.
In the form of a powder, the salt forms the coating that you see on medications and vitamins.
Magnesium stearate may stick to your hands and feel greasy when you touch it.
Makers of many processed foods, cosmetics, and pharmaceuticals also add magnesium stearate to their products.
What Is the Purpose of Magnesium Stearate?
Medications. Companies call magnesium stearate a “flow agent.”
Magnesium stearates main job is to keep the ingredients in a capsule from sticking together.
Magnesium stearate also forms a barrier between the medicines and the machines that make them.
The powder improves the consistency and quality of the medication capsules.
What is magnesium stearate?
Magnesium stearate is a simple salt made of two common nutritional substances, the mineral magnesium and the saturated fat stearic acid.
Magnesium stearate is used as a flow agent, lubricant, binder or anti-caking agent in the production of many nutritional supplements and pharmaceuticals.
Magnesium and stearic acid are bound together to create magnesium stearate.
We all know what magnesium is… it’s an essential mineral abundant in dark green leafy vegetables.
Stearic acid is a saturated fatty acid found in many foods including eggs, chicken, grass-fed beef, coconut oil, walnuts, cheese, chocolate, salmon and human breast milk, to name just a few.
Magnesium stearate is recognized as physiologically safe.
Therefore Magnesium stearate is used by the cosmetics and pharmaceutical industry to improve the free-flowing properties, and is added as anti-caking agents to powders.
One of the principle uses of magnesium stearate is as a tablet excipient in pharmaceutical dosage forms.
Thermostable magnesium stearate is used as a lubricant and release agent for the processing of thermosets and thermoplastics.
Why is Magnesium stearate necessary for production?
The use of magnesium stearate in the manufacturing process helps ensure consistency and quality control.
In Magnesium stearate’s absence, the machinery that creates the capsules can ‘jam’ up.
This would cause potential variances in the amount of active ingredients between capsules.
What are sources of magnesium stearate?
Stearic acid is derived from animal sources or plant-based sources.
Vegetarian sources of magnesium stearate include palm oil, coconut oil and vegetable oil.
“plant based” is used as their source of magnesium stearate.
Safety of Magnesium Stearate
There are claims being made in the media and on the internet that magnesium stearate suppresses immune T-cell function and causes the collapse of cell membrane integrity in helper T-cells.
Is there any scientific proof to support this?
There is no human data to support this hypothesis.
There is one study from 1990 that examined T-cells of mice.
The T-cells were immersed in stearic acid (not magnesium stearate) in a Petri dish.
The result was that the mouse T-cell activity was compromised.
Humans are not mice.
In the case of the 1990 study, Magnesium stearate was noted that mice lack the enzyme (delta-9 desaturase) that allows stearic acid (again not magnesium stearate) to convert to oleic acid (healthy monounsaturated omega-9 fatty acid).
Human T-cells do contain the delta-9 desaturase enzyme that converts stearic acid to oleic acid.
Human T-cells will not develop toxic build-up when exposed to stearic acid.
What is a safe level of consumption of magnesium stearate?
The scientific community considers a safe amount of magnesium stearate for human consumption to be below 2,500 mg/kg per day.
For a 150-pound adult this is equivalent to 170,000 mg per day.
Another function of the powder is to slow the absorption and breakdown of drugs.
This way, your body absorbs them in the correct area of your bowel.
Without magnesium stearate, it would be hard to predict a medication’s outcome, quality, and consistency.
Cosmetics.
In the cosmetic world, magnesium stearate is a helpful ingredient for many things.
Magnesium stearate acts as a bulking agent, an anti-caking agent, a colorant, and more.
Here, it is a low-hazard product, but data on this is limited.
Formula: C36H70MgO4 / Mg(C18H35O2)2
Molecular mass: 591.3
Melting point: 88°C
Density: 1.02 g/cm³
Solubility in water: none
Flash point: see Notes
The Health Effects of Magnesium Stearate
Magnesium stearate is generally safe to consume, but too much of it can have a laxative effect.
In large amounts, it can irritate the mucus lining of the bowels.
This may trigger a bowel movement or diarrhea.
Immune function. The powder may weaken your immune T-cell function.
Studies on this effect are still in the early stages.
Magnesium stearate tends to form a film around the molecules in tablets and capsules.
This slows down the digestive enzymes as they now have to break through this coating to enter the molecule.
This could be a major health issue, especially in individuals with impaired digestion or digestive problems.,
Pesticide concerns.
Stearate sometimes comes from cottonseed oil.
Some people worry that it may have pesticides that can be dangerous when consumed.
Magnesium stearate goes through an intense purification process before being used in medications.
Another concern is that cottonseed oil is genetically modified.
But the chemical structure of stearic acid remains the same regardless of its source.
Nutrients and drug absorption.
There is some concern that magnesium stearate might keep the body from absorbing nutrients the way it should.
One study found that tablets with magnesium stearate take longer to dissolve than those without.
Compound Formula: [CH3(CH2)16CO2]2Mg
Molecular Weight: 591.24
Appearance: White Powder
Melting Point: 200°C
Boiling Point: N/A
Density: N/A
Solubility in H2O: N/A
Exact Mass: 590.512452 g/mol
Monoisotopic Mass: 590.512452 g/mol
Other research found that how long magnesium stearate takes to dissolve has no effect on a drug’s effectiveness.
Magnesium stearate also doesn’t change the dissolution of the tablet or the potency of the supplement or drug.
Biofilms. There are also concerns that magnesium stearate can cause the formation of harmful biofilms in the digestive system.
Biofilms happen when groups of bacteria form a protective barrier.
These claims come from the fact that soap has magnesium stearate and makes a scum film.
But your intestinal lining is different from your bathroom walls or doors and won’t have the same scum film.
The National Center for Biotechnology Information (NCBI) also says Magnesium stearate is safe for use in small quantities.
Magnesium stearate recommends fewer than 2,500 milligrams (mg) per kilogram daily.
This equals about 170,000 mg for a 150-pound adult, much more than what you’d take in supplements.
MAGNESIUM STEARATE
557-04-0
Magnesium distearate
Magnesium octadecanoate
Octadecanoic acid, magnesium salt
Dibasic magnesium stearate
Stearic acid, magnesium salt
magnesium(ii) stearate
magnesium;octadecanoate
magnesium dioctadecanoate
UNII-70097M6I30
Octadecanoic acid, magnesium salt (2:1)
CHEBI:9254
Synpro 90
70097M6I30
MFCD00036391
Petrac MG 20NF
Magnesium stearate ksm4016 and fsm4014 can be delivered through the accompanying system: first get the sodium stearate through the saponification between stearic corrosive and sodium; at that point the sodium stearate has twofold deterioration response with magnesium sulfate to get the completed item.
Magnesium stearate, a waxy, lamellar (platy) solid, is a widely used excipient in pharmaceutical technology.
Primarily, magnesium stearate is added to a formulation in order to modify compaction behavior and reduce ejection forces from tablet dies and is available in a range of grades having similar or different surface areas.
Magnesium stearate is ideal for specific surface area measurements according to USP <846> Method II (volumetric method) and the well-known BET calculation described therein.
What Is Magnesium stearate?
The Stearate salts, including Lithium Stearate, Aluminum Distearate, Aluminum Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate, and Zinc Stearate are fine, white powders with a slight fatty odor.
In cosmetics and personal care products, Stearate salts are used mainly in the formulation of makeup products such as eyeliner, eyeshadow, mascara, lipsticks, blushers, face powders and foundations.
They are also used in fragrances, deodorants, and hair and skin care products.
Why is Magnesium stearate used in cosmetics and personal care products?
The Stearate salts are generally used for their lubricating properties.
They also help to keep emulsions from separating into their oil and liquid components.
The Stearate salts increase the thickness of the lipid (oil) portion of cosmetics and personal care products and reduce the clear or transparent appearance of finished products.
Why Measure the Surface Area of Magnesium Stearate?
The specific surface area of any solid relates to Magnesium stearates particle morphology including porosity, aspect ratio, and fineness, and can be indicative of its manufacturing and thermal history and its suitability in a specific application.
The preferred physical form of magnesium stearate has a lamellar structure that has a low shearing force, thereby imparting a means of dry lubrication between a compacted powder and the walls of a tablet die, when properly blended with the active pharmaceutical ingredient and other excipients.
Magnesium stearate is also largely hydrophobic, however, and can impart undesirable effects to the dissolution profile of a solid dosage form.
Pharmaceutical formulations are optimized with respect to both effective lubrication and desirable Bio-availability, which can be mutually counter-productive.
The surface area of pharmaceutical-grade magnesium stearate is formally recognized as an important characteristic and its analysis is formalized in the USP Monograph “Magnesium Stearate.”
The analytical method is described in USP chapter <846> together with conditions specific to magnesium stearate stated in the aforementioned monograph.
Typical applications
ABS / High Impact Polystyrene Manufacturing and Processing
Employed as internal lubricant (most used are grades S and SP)
Expanded Polystyrene
As a coating agent and external lubricant.
Polystyrene Manufacturing
Is a lubricant in the manufacturing phase.
Cosmetics
High class face powders, toothpaste, etc.
Building Materials
Applied as hydrophobic agent in mortars and plasters (most used are S grades)
Food and Feed
Used as anti caking agent.
Pharmaceuticals
Magnesium Stearate Phar and Eur.Phar used in the production of tables.
Scientific Facts:
The commercial stearic acid from which the Stearate salts are manufactured is actually a mixture of monocarboxylic acids obtained from animal and/or vegetable sources.
Linear Formula: [CH3(CH2)16CO2]2Mg
MDL Number: MFCD00036391
EC No.: 209-150-3
Beilstein/Reaxys No.: 3919702
Pubchem CID: 11177
IUPAC Name: magnesium; octadecanoate
SMILES: CCCCCCCCCCCCCCCCCCC(=O)[O-].CCCCCCCCCCCCCCCCC(=O)[O-].[Mg+2]
InchI Identifier: InChI=1S/2C18H36O2.Mg/c2*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;/h2*2-17H2,1H3,(H,19,20);/q;;+2/p-2
InchI Key: HQKMJHAJHXVSDF-UHFFFAOYSA-L
Magnesium stearate is derived from animal as well as plant sources.
However, most companies use a plant sourced one that is derived from either cotton seed oil, canola oil, or palm oil.
Cotton happens to be one of the crops with maximum pesticide residue.
Canola oil also happens to be a high risk genetically modified crop.
And lastly, Palm oil contains palmitic acid which is identified by the World Health Organization (WHO) as a cardiovascular disease contributor.
Calcium carbonate (CaCO3) is carbonic salt of calcium and abundant in nature.
Magnesium stearate is the main component of stone, the shell of marine animals, and shell eggs.
To produce for commercial production, CaCO3 is obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.
There are many applications of CaCO3 as a food additive with different purposes including as a dietary supplement, dough conditioner, pH control agent, modifier, stabilizer, and texturizing agent for chewing gum.
Magnesium stearate (MgSt) is a magnesium salt of stearic acid, which is widely used as a lubricant for tablets, capsules and powders in the pharmaceutical industry.
Furthermore, Magnesium stearate is also used to bind sugar in hard candies, such as mints, and is a common ingredient in baby formulas.
IUPAC name
Magnesium octadecanoate
Safety
Magnesium stearate is generally considered safe for human consumption at levels below 2500 mg/kg per day and is classified in the United States as generally recognized as safe (GRAS).
In 1979, the FDA’s Subcommittee on GRAS 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 be expected in the future.”
NS-M (salt)
SM-P
Magnesium stearate, 3.8-5.0% Mg
Synpro Magnesium Stearate 90
HSDB 713
EINECS 209-150-3
Magnesium distearate, pure
Stearic acid magnesium salt
NP 1500
SM 1000
Magnesium stearate [JAN:NF]
AI3-01638
Magnesium Stearate NF
SCHEMBL935
Rashayan Magnesium Stearate
ACMC-1AY89
C36H70MgO4
Magnesium Stearate is a fine white powders with a slight fatty odor.
In cosmetics and personal care products, Stearate salts are used mainly in the formulation of makeup products such as eyeliner, eyeshadow, mascara, lipsticks, blushers, face powders and foundations.
Magnesium stearate are also used in fragrances, deodorants, and hair and skin care products.
octadecanoic acid magnesium salt
Magnesium stearate (JP17/NF)
CHEMBL2106633
DTXSID2027208
Stearic Acid Magnesium(II) Salt
AKOS015915201
DB14077
H416
FT-0602789
S0238
D02189
A830764
Q416713
UNII-R4OXA9G5BV component HQKMJHAJHXVSDF-UHFFFAOYSA-L
What is magnesium stearate?
Magnesium stearate is comprised of the saturated fat, stearic acid, and the mineral magnesium.
Magnesium stearate is considered to be a “flow agent”.
Magnesium stearate is basically a powdered (oily to the touch) lubricant that is added to the rest of the supplement to help Magnesium stearate slide easily through automatic capsule machines.
Magnesium stearate is still possible to make supplements without magnesium stearate, we do, but most companies will opt to save the time and money and just include Magnesium stearate in every supplement they make.
Why would anyone use magnesium stearate?
The reason most supplement companies use magnesium stearate in their products is because Magnesium stearate is cheaper and much easier than making products without Magnesium stearate.
The majority of factories will tell you that they need to use Magnesium stearate.
Magnesium stearate is not true, but Magnesium stearate makes their lives easier.
If you ask them to make a product without magnesium stearate, many factories will refuse because Magnesium stearate is physically much harder to run the machines without using Magnesium stearate.
What is stearic acid made from?
The stearic acid used to make magnesium stearate is generally from genetially modified (GMO) cottonseed or palm oil.
These oils are then ‘hydrogenated’ by superheating them and putting them under high pressure for several hours in the presense of a metal catalyst.
Where is magnesium stearate usually made?
Here is a press release about the magnesium stearate industry.
The global market is growing at an average of 6.4% per year.
The majority of the world’s magnesium stearate is produced in China.
An interesting quote from the press release:
“China has emerged as the global leader in the market in terms of consumption and production of magnesium stearate.”
Is magnesium stearate natural?
No Magnesium stearate is not.
Magnesium stearate is a highly processed hydrogenated oil, usually made from genetically modified cottonseed or palm oil.
Is magnesium stearate a good source of magnesium?
No Magnesium stearate is not.
Try our non-buffered magnesium bisglycinate with no magnesium stearate for an excellent source of magnesium.
What is the difference between magnesium and magnesium stearate?
“Magnesium” is generally referred to as a type of healthy dietary magnesium.
There are many types of dietary “magnesium”.
“Magnesium stearate” is a filler.
Magnesium stearates a flow agent to help lubricate machines.
They are totally different.
209-150-3 [EINECS]
3919702 [Beilstein]
557-04-0 [RN]
70097M6I30
Dibasic magnesium stearate
Dioctadécanoate de magnésium [French] [ACD/IUPAC Name]
Magnesium dioctadecanoate [ACD/IUPAC Name]
MAGNESIUM OCTADECANOATE
Magnesium stearate [JAN] [JP15] [NF] [USP]
Magnesiumdioctadecanoat [German] [ACD/IUPAC Name]
MFCD00036391 [MDL number]
OCTADECANOIC ACID MAGNESIUM SALT
Magnesium stearate is extremely difficult to study because Magnesium stearate is both a complex mixture of chemical species and Magnesium stearate can exist in multiple forms each of which have different properties.
Compounding the situation is the fact that Magnesium stearate is present in very low quantities in most tablets; making Magnesium stearate even more difficult to study.
CPD researchers have synthesized their own magnesium stearate so that they can both better understand how magnesium stearate’s composition affects the tablet properties and also study how Magnesium stearate changes form once Magnesium stearate is compressed into tablets.
By understanding how magnesium stearate affects the tablet making process, companies can better predict how to add Magnesium stearate into the mix, at what ratios, and what grades to get the optimal tablet without loss of product from malformed tablets and to make safer and better tablets that will help patients.
Magnesium stearate is an extremely problematic additive to study because of Magnesium stearates complex nature and low concentration in a tablet.
With the CPD approach of making our own magnesium stearate enables us to study Magnesium stearate using advanced analytical techniques that have not been used to study Magnesium stearate previously.
Most importantly, we can now study what happens to the magnesium stearate when Magnesium stearate is compressed into tablet form.
When this is done Magnesium stearate impacts both magnesium stearate’s performance as a lubricant and the potential negative effects upon how a tablet dissolves.
Octadecanoic acid, magnesium salt
Octadecanoic acid, magnesium salt (2:1) [ACD/Index Name]
stearic acid magnesium salt
Stearic acid, magnesium salt
synpro 90
Synpro Magnesium Stearate 90
WI4390000
(OCTADECANOYLOXY)MAGNESIO OCTADECANOATE
[557-04-0]
212132-26-8 [RN]
EINECS 209-150-3
magnesium distearate
Magnesium stearate (contain palmitic acid)
Magnesium Stearate NF
Magnesium Stearate NF EP FCC Kosher
Magnesium stearate, EP, USP grade
MAGNESIUM(2+) DIOCTADECANOATE
MAGNESIUM(2+) ION BIS(N-OCTADECANOATE)
magnesium(2+) ion bis(octadecanoate)
Magnesium(II) Stearate
magnesiumstearate
PARTECK LUB MST
Petrac MG 20NF
SM-P
UNII:70097M6I30
UNII-70097M6I30
硬脂酸镁 [Chinese]