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557-04-0

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557-04-0 Usage

Description

Magnesium stearate, also known as octa decanoic acid, magnesium salt, is a white powder that becomes solid at room temperature. It has the chemical formula Mg(C18H35O2)2 and 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.

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.

Check Digit Verification of cas no

The CAS Registry Mumber 557-04-0 includes 6 digits separated into 3 groups by hyphens. The first part of the number,starting from the left, has 3 digits, 5,5 and 7 respectively; the second part has 2 digits, 0 and 4 respectively.
Calculate Digit Verification of CAS Registry Number 557-04:
(5*5)+(4*5)+(3*7)+(2*0)+(1*4)=70
70 % 10 = 0
So 557-04-0 is a valid CAS Registry Number.
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

557-04-0 Well-known Company Product Price

  • Brand
  • (Code)Product description
  • CAS number
  • Packaging
  • Price
  • Detail
  • Alfa Aesar

  • (A16244)  Magnesium stearate   

  • 557-04-0

  • 250g

  • 440.0CNY

  • Detail
  • Alfa Aesar

  • (A16244)  Magnesium stearate   

  • 557-04-0

  • 1000g

  • 925.0CNY

  • Detail
  • USP

  • (1374340)  Magnesiumstearate  United States Pharmacopeia (USP) Reference Standard

  • 557-04-0

  • 1374340-5G

  • 4,662.45CNY

  • Detail
  • Aldrich

  • (415057)  Magnesiumstearate  technical grade

  • 557-04-0

  • 415057-25G

  • 478.53CNY

  • Detail
  • Aldrich

  • (415057)  Magnesiumstearate  technical grade

  • 557-04-0

  • 415057-1KG

  • 866.97CNY

  • Detail

557-04-0SDS

SAFETY DATA SHEETS

According to Globally Harmonized System of Classification and Labelling of Chemicals (GHS) - Sixth revised edition

Version: 1.0

Creation Date: Aug 12, 2017

Revision Date: Aug 12, 2017

1.Identification

1.1 GHS Product identifier

Product name magnesium distearate

1.2 Other means of identification

Product number -
Other names MAGNESIUM DISTEARATE

1.3 Recommended use of the chemical and restrictions on use

Identified uses For industry use only. Surfactants
Uses advised against no data available

1.4 Supplier's details

1.5 Emergency phone number

Emergency phone number -
Service hours Monday to Friday, 9am-5pm (Standard time zone: UTC/GMT +8 hours).

More Details:557-04-0 SDS

557-04-0Relevant articles and documents

Continuous preparation method of metal fatty acid salt

-

Paragraph 0088; 0089; 0090; 0091, (2019/04/04)

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.

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

-

Page/Page column, (2014/04/18)

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

Itsadanont, Sawwalak,Scamehorn, John F.,Soontravanich, Sukhwan,Sabatini, David A.,Chavadej, Sumaeth

, p. 849 - 857 (2014/11/08)

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.

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