557-04-0

Basic information

• Product Name: Magnesium stearate
• Synonyms: stearatedemagnesium;MAGNESIUM STEARATE;MAGNESIUM OCTADECANOATE;MAGENSIUM STEARATE;STEARIC ACID MAGNESIUM SALT;OCTADECONIC ACID MAGNESIUM SALT;OCTADECANOIC ACID MAGNESIUM SALT;Magnesium Stearate Bp
• CAS NO: 557-04-0
• Molecular Formula: 2C₁₈H₃₅O₂*Mg
• Molecular Weight: 591.24
• EINECS: 209-150-3
• Product Categories: Cosmetic Ingredients & Chemicals;Building Blocks;Carbonyl Compounds;Carboxylic Acid Salts;Chemical Synthesis;Organic Building Blocks;Pharmacopoeia;Pharmacopoeia A-Z;food and drug safety;Health and medical care;Food additives
• Mol File: 557-04-0.mol

Chemical Properties

• Melting Point: 200 °C(lit.)
• Boiling Point: 359.4 °C at 760 mmHg
• Flash Point: 162.4 °C
• Appearance: White/Fine Powder
• Density: 1.028g/cm3
• Storage Temp.: Store at RT.
• Solubility: alcohol: insoluble
• Water Solubility: Insoluble
• Stability: Stable. Incompatible with strong oxidizing agents.
• Merck: 14,5690
• BRN: 3919702
• CAS DataBase Reference: Magnesium stearate(CAS DataBase Reference)
• NIST Chemistry Reference: Magnesium stearate(557-04-0)
• EPA Substance Registry System: Magnesium stearate(557-04-0)

Safety Data

• Hazard Codes: Xi
• Statements: 36/37/38
• Safety Statements: 26-37/39
• RTECS: WI4390000
• TSCA: Yes
• Hazardous Substances Data: 557-04-0(Hazardous Substances Data)

Usage

Uses

Used in Food Industry:
Magnesium stearate is used as an emulsifier, binder, thickener, anticaking, lubricant, release, and antifoaming agent for its good lubricating properties due to its hydrophobic nature and ability to reduce friction between tablets and die wall during the ejection process.
Used in Pharmaceutical Industry:
Magnesium stearate is used as an inactive ingredient in the production of pharmaceutical tablets, capsules, and powders. It serves as a lubricant or die release in tableting pressed candies and is also used in sugarless gum and mints. Additionally, it is used as an anti-adherent in the manufacture of medical tablets, capsules, and powders, preventing ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets.
Used in Plastic Industry:
Magnesium stearate is used as a mold-releasing agent for tablets (need meeting the medicine criterion) and as an emulsifying agent in cosmetics. It can also conjugate with Ca Soap as a stabilizer of PVC.
Used in Other Applications:
Magnesium stearate is a major component of "bathtub rings" and is used to bind sugar in hard candies like mints. It is also a common ingredient in baby formulas and baby dusting powders. 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, with some nutritional supplements specifying that the magnesium stearate used is sourced from vegetables.

Surfactant

Magnesium stearate is a kind of fatty acid salt type anionic surfactant with its appearance being white powder with slight special smell and creamy feeling. It can be soluble in hot aliphatic hydrocarbons, hot arene and hot grease but insoluble in alcohol and water with being decomposed into stearic acid and corresponding magnesium salts in case of acid. Magnesium stearate has an excellent adhesion property to the skin with excellent lubrication property. It can be applied to powder products in cosmetics and can improve adhesion and lubrication. Magnesium stearate can be used as PVC heating stabilizers with the stability performance being similar to calcium stearate and can be combined with zinc or calcium soaps for being applied to food packaging material but without very wide application. Magnesium stearate can be used as a mold releasing agent of plastic products, face powder of cosmetics, the raw material of skin ointment, the powder molding tablet of pharmaceutical tablets and translucent flatting agent of paint. Laboratory, through the replacement reaction of sodium stearate and magnesium sulfate, is able to get finished product of magnesium stearate and can also apply the combination reaction between edible solid organic acids (stearic acid, palmitic acid) mixture and magnesium oxide compounds and further refinement to make it.

Pharmaceutical Applications

Magnesium stearate is the magnesium salt of stearic acid that possess lubricating properties and hence prevents ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets. It has been used as a tablet and capsule lubricant. It has also been used for preparing microcapsules. Dry coating of drugs with magnesium stearate leads to flow improvement, flow-aid and lubrication effects, tabletability as well as non-inhibited dissolution rate.

Pharmaceutical Applications

Magnesium stearate is widely used in cosmetics, foods, and pharmaceutical formulations. It is primarily used as a lubricant in capsule and tablet manufacture at concentrations between 0.25% and 5.0% w/w. It is also used in barrier creams.

Production method

Magnesium stearate is produced by the reaction of sodium stearate with magnesium salts or by treating magnesium oxide with stearic acid (Nora 2005). Magnesium stearate can be produced through the following procedure: first get the sodium stearate through the saponification between stearic acid and sodium; then the sodium stearate has double decomposition reaction with magnesium sulfate to get the finished product. Stearic acid and water was added to the reaction pot and heated to 85 ℃, stirring to dissolve, slowly add them to the sodium hydroxide solution preheated to 75 ℃. After the saponification reaction was completed, the temperature was controlled at 72 ℃ and slowly added to the magnesium sulfate solution preheated to 55 ℃ upon stirring. After metathesis, apply centrifuge to remove the water. The filtering cake was washed with water until sulfate ion requirement is met, then dry, apply air drying, sifting to obtain the finished products with the yield of stearic acid being 100%. It is produced through the combination reaction between magnesium oxide and food grade solid mixed fatty acids (mainly stearic acid) and further refinement.

Toxicity

Magnesium stearate is considered to be non-toxic, and is Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration (FDA). It is approved for use in food and dietary supplements as a lubricant and release agent, emulsifier, binder, thickener, anticaking and anti-foaming agent. In addition to the United States, it is accepted as a safe food additive in Europe, the UK, and Canada. A specification for magnesium stearate is also included in the Food Chemicals Codex (FCC), a collection of internationally recognized standards for the purity and identity of food ingredients. According to the FDA, there is no evidence to suggest that magnesium stearate causes adverse effects when used “at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future.” Animal research shows that orally-administered magnesium stearate is non-toxic far beyond the commonly used amounts. Additionally, as recently as 2015, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) conducted a safety assessment of magnesium stearate and found no concerns regarding its continued use or safety.

Preparation

Magnesium stearate is created by the reaction of sodium stearate with magnesium sulfate.

Production Methods

Magnesium stearate is prepared either by the interaction of aqueous solutions of magnesium chloride with sodium stearate or by the interaction of magnesium oxide, hydroxide, or carbonate with stearic acid at elevated temperatures.

Biochem/physiol Actions

Magnesium stearate is the magnesium salt of stearic acid that possess lubricating properties and hence prevents ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets. Dry coating of drugs with magnesium stearate leads to flow improvement, flow-aid and lubrication effects, tabletability as well as non-inhibited dissolution rate.

Safety Profile

Slightly toxic by ingestion. Spontaneously combustible. When heated to decomposition it emits acrid smoke and toxic fumes.

Safety

Magnesium stearate is widely used as a pharmaceutical excipient and is generally regarded as being nontoxic following oral administration. However, oral consumption of large quantities may produce a laxative effect or mucosal irritation. No toxicity information is available relating to normal routes of occupational exposure. Limits for heavy metals in magnesium stearate have been evaluated in terms of magnesium stearate worstcase daily intake and heavy metal composition. Toxicity assessments of magnesium stearate in rats have indicated that it is not irritating to the skin, and is nontoxic when administered orally or inhaled. Magnesium stearate has not been shown to be carcinogenic when implanted into the bladder of mice. LD50 (rat, inhalation): >2 mg/L LD50 (rat, oral): >10 g/kg

storage

Magnesium stearate is stable and should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Incompatible with strong acids, alkalis, and iron salts. Avoid mixing with strong oxidizing materials. Magnesium stearate cannot be used in products containing aspirin, some vitamins, and most alkaloidal salts.

Regulatory Status

GRAS listed. Accepted as a food additive in the USA and UK. Included in the FDA Inactive Ingredients Database (oral capsules, powders, and tablets; buccal and vaginal tablets; topical preparapreparations; intravitreal implants and injections). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients. Listed on the US TSCA inventory.

InChI:InChI=1/C18H36O2.Mg/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;/h2-17H2,1H3,(H,19,20);/q;+2/p-1

Upstream product

• 69-65-8 mannitol 
• 57-11-4 stearic acid 

Downstream Products

• 39133-31-8 trimebutine 
• 5638-76-6 betahistine 
• 6284-40-8 1-deoxy-1-(methylamino)-D-glucitol 
• 58-08-2 3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione 
• 547-66-0 magnesium(II) oxalate 
• 57-11-4 stearic acid 

Relevant articles and documents

Continuous preparation method of metal fatty acid salt

The invention relates to a continuous preparation method of metal fatty acid salt. The continuous preparation method of the metal fatty acid salt comprises the step of continuously enabling fatty acidand metal hydroxides to react in a solvent and prepare the metal fatty acid salt in a microchannel reactor or pipeline reactor. The preparation method disclosed by the invention can control the particle diameter of a product material to be within 70nm and 1000nm, and the particle diameter of the product material can be adjusted as needed; the metal fatty acid salt is simple in preparation method,short in technological process, few in three wastes (waste water, waste residues and waste gas), beneficial to environmental protection and suitable for industrial production; the reactor used in theinvention has short reaction time, high safety, high efficiency and large productivity, and can realize continuous production, furthermore, the space utilization rate of workshops is high, and mass production can be realized; by adopting the preparation method disclosed by the invention, the solvent can be recycled to lower the production cost; and the preparation method has high conversion rateof raw materials, stable quality and high purity.

Magnesium stearate and preparation process thereof

The invention belongs to the technical field of chemical engineering, and particularly relates to magnesium stearate and a preparation process thereof. The preparation process includes the following steps: (1) subjecting tristearin and water to hydrolysis under the action of catalyst and antioxidant; (2) adding magnesium oxide and catalyst step by step, and performing condensation, dehydration and salifying to synthesize magnesium stearate. The magnesium stearate provided is industrial-grade magnesium stearate, and is low in raw material cost, high in production yield, good in color, low in free acid content and stable in quality. In the preparation process of magnesium stearate, discharge of wastewater containing chlorine and sulfate ions is avoided, the production process is safe and environment friendly, and overall production cost is low. The provided magnesium stearate is high in quality, and is more practical and comparable than similar products on the market in practical application.

Glutathione and Acetaminophen Composition and Preparation Method Thereof

A pharmaceutical composition of glutathione and acetaminophen and preparation method thereof. The active ingredients of the composition include glutathione with composition ration of 0.1%?99.9% and acetaminophen with composition ratio of 99.9%?0.1%. The further purpose of the invention is to prepare glutathione and acetaminophen composition (raw materials) into various pharmaceutically acceptable dosage forms, such as tablets, sustained/controlled release preparations, capsules, pills, syrups, films, granules, oral solutions, oral suspensions, oral emulsions and oral powders. The beneficial effects of the invention is reflected in that glutathione and acetaminophen combination can effectively prevent the liver cell damage and necrosis caused by acetaminophen overdose and is strongly in favor of cancer pain relief and chemotherapy.

Use of selectively moisture-adjusted tabletting material in the production of mechanically stable tablets which contain at least one hydrate-forming active substance and/or adjuvant relevant to the mechanical stability of the tablets, particularly arginine-containing tablets

The present invention relates inter alia to the use of selectively moisture-adjusted tabletting material in the preparation of mechanically stable oral tablets which contain at least one hydrate-forming active substance and/or adjuvant relevant to the mechanical stability of the tablets, particularly arginine-containing oral tablets.

Dissolution of soap scum by surfactant part I: Effects of chelant and type of soap scum

The equilibrium solubilities of two model soap scums [calcium stearate and magnesium stearate: Ca(C18)2 and Mg(C18) 2] were measured in aqueous solutions containing three different types of surfactants: methyl ester sulfonate (MES) as an anionic; alcohol ethoxylate (EO9) as a nonionic; and dimethyldodecylamine oxide (DDAO) as an amphoteric with and without a chelating agent [disodium ethylenediaminetetraacetate (Na2EDTA)]. The solubility of calcium soap scum was generally higher than that of magnesium soap scum, the exception being some DDAO systems. The use of the DDAO surfactant with the Na 2EDTA chelating agent at high pH gives the highest solubilities of both studied soap scums. The soap scum solubility is on the order of 2,000 times that in water at high pH. The DDAO is the most effective surfactant under all conditions. The MES is more effective than the EO9 at low pH with the opposite trend observed at high pH. The synergism from added chelant is generally greater at higher pH and is greatest for DDAO followed by EO9.

METHODS AND COMPOSITIONS USING ERGOTHIONEINE TO TREAT A VARIETY OF HEALTH RELATED FACTORS

In one embodiment, a composition containing ergothioneine and/or synthesized l-ergothioneine and one or more compounds selected from the group consisting of vitamin B-12, glucosamine sulfate, calcium ascorbate, turmeric extract, black pepper extract, hyaluronic acid, collagen, glycosaminoglycans, cat's claw extract, acai berry; and white willow bark extract is provided to a mammal to improve a variety of health related factors, including but not limited to brain health, joint health, eye health, mitondchorial optimization/improvement and reduction of inflammation and pain in a mammal.

Pharmaceutical composition for the prevention and treatment of liver disease comprising a lonicera caerulea L. Var. Edulis extract

Disclosed herein is a pharmaceutical composition having preventative and therapeutic effects on liver diseases, comprising an extract from Lonicera caerulea L. var. edulis. The composition has preventative and therapeutic effects on hepatitis, liver cirrhosis, fatty liver, and the like.

COMPOSITION CONTAINING PEPTIDE AS THE ACTIVE INGREDIENT

The invention provides a composition used for promoting glucose uptake, which comprises a peptide having an effect of promoting glucose uptake as the active ingredient, as well as a composition comprising a dipeptide containing leucine and/or isoleucine as the active ingredient. The composition is effective in preventing or treating diabetes mellitus or an elevation of blood glucose level, in promoting glycogen storage, or in enhancing physical strength, enhancing athletic ability, improving endurance performance or relieving fatigue.

Formulations comprising selective androgen receptor modulators

The present invention relates to pharmaceutical compositions and formulations comprising a novel class of androgen receptor targeting agents (ARTA) which demonstrate androgenic and anabolic activity of a nonsteroidal ligand for the androgen receptor. The agents define a new subclass of compounds which are selective androgen receptor modulators (SARM) which are useful for a) male contraception; b) treatment of a variety of hormone-related conditions, for example conditions associated with Androgen Decline in Aging Male (ADAM), such as fatigue, depression, decreased libido, sexual dysfunction, erectile dysfunction, hypogonadism, osteoporosis, hair loss, anemia, obesity, sarcopenia, osteopenia,osteoporosis, benign prostate hyperplasia, alterations in mood and cognition and prostate cancer; c) treatment of conditions associated with Androgen Decline in Female (ADIF), such as sexual dysfunction, decreased sexual libido, hypogonadism, sarcopenia, osteopenia, osteoporosis, alterations in cognition and mood, depression, anemia, hair loss, obesity, endometriosis, breast cancer, uterine cancer and ovarian cancer; d) treatment and/or prevention of chronic muscular wasting; and/or e) decreasing the incidence of, halting or causing a regression of prostate cancer. The present invention provides pharmaceutical compositions comprising the selective androgen receptor modulator compounds, together with pharmaceutically acceptable excipients.

Naphthalene derivatives, their production and use

A composition containing a compound of the formula: wherein A is a nitrogen-containing heterocyclic group which may be substituted, R1 is a hydrogen atom, hydrocarbon group which may be substituted, or monocyclic aromatic heterocyclic group which may be substituted, R2 is a hydrogen atom or a lower alkyl group which may be substituted, R3, R4, R5, R6, R7, R8 and R9 are independently a hydrogen atom, a hydrocarbon group which may be substituted, a hydroxy group which may be substituted, a thiol group which may be substituted, an amino group which may be substituted, an acyl group or a halogen atom, a salt thereof or a prodrug thereof has steroid C17,20-lyase inhibitory activity, and is useful for preventing and treating for example, primary cancer of malignant tumor, its metastasis and recurrence thereof.