Magnesium Stearate
557-04-0CCCCCCCCCCCCCCCCCC(=O)[O-].CCCCCCCCCCCCCCCCCC(=O)[O-].[Mg+2]HQKMJHAJHXVSDF-UHFFFAOYSA-LMagnesium distearate is an organic magnesium salt and a magnesium salt.
557-04-0DTXSID2027208CHEMBL2106633CHEBI:9254Other Classes -> Stearates
Other Classes -> Stearates
Cosmetic ingredients (Magnesium Stearate) -> CIR (Cosmetic Ingredient Review)
Moisturising; Cosmetic colorant; Anticaking; Bulking
Odorless
Faint, characteristic odor
1.028
1.02 g/cm³
LUMPS
Fine, bulky, white powder
Soft, white, light powder
IN 100 CC WATER: 0.003 G @ 15 °C; 0.004 G @ 25 °C; 0.008 G @ 50 °C
IN 100 CC SOLVENT @ 25 °C: 0.020 G IN ALCOHOL; 0.003 G IN ETHER
Solubility in water: none
안전 정보는 참고용이며, 공급업체의 물질안전보건자료(SDS), 관련 법규 및 전문가 평가를 대체하지 않습니다.
This chemical does not meet GHS hazard criteria for 54.9% (280 of 510) of all reports.
Warning
H315 (22.4%): Causes skin irritation [Warning Skin corrosion/irritation]
P261, P264, P264+P265, P271, P273, P280, P302+P352, P304+P340, P305+P351+P338, P319, P321, P332+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement)
Aggregated GHS information provided per 510 reports by companies from 20 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.
Warning
Chemical: Octadecanoic acid, magnesium salt
Octadecanoic acid, magnesium salt (2:1) is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Octadecanoic acid, magnesium salt (2:1) are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)
Octadecanoic acid, magnesium salt: Does not have an individual approval but may be used under an appropriate group standard
This TLV Documentation applies only to stearic acid and magnesium, sodium, and zinc stearates. It excludes stearates of other metals. TLV Basis is lower respiratory tract irritation. No acute systemic effects of stearic acid have been reported after ingestion. . . . Sprague-Dawley rats fed stearic acid in their diet at 3000 ppm for 209 days showed 'severe pulmonary infection consisting of tracheobronchitis, lobular pneumonia, lipoid histiocytic response, and abscess formation.' [ACGIH] See Stearic acid.
CIR ingredient: Magnesium Stearate
Used in cosmetics, pharmaceuticals, food additives, waterproofing agents, plastic stabilizers, emulsifiers, and rubber lubricants and dusting agents; Stearic acid occurs naturally in human and animal fats and oils and in some vegetable oils, including cocoa oil. Stearic acid can be prepared from animal fat (triglyceride) by treating with water at high temperature, leading to hydrolysis of triglycerides, or by hydrogenation of unsaturated vegetable oils such as cottonseed oil. [ACGIH]
Used in baby dusting powders; as lubricant for plastics; as emulsifying agent in cosmetics; as drier in paints and varnishes; as flatting agent; as anticaking agent in foods and fire extinguishers; and as lubricant in making pharmaceutical tablets; [HSDB]
Painting (Pigments, Binders, and Biocides) [Category: Paint]
IN BABY DUSTING POWDERS
Dusting powder, lubricant for plastics, emulsifying agent in cosmetics, drier in paints and varnishes and flatting agent.
2023: 2,500,000 - <4,000,000 lb
(1972) 2.16X10+9 GRAMS
(1975) 1.79X10+9 GRAMS
(1984) 1.08X10+10 g
MAGNESIUM STEARATE /IS/ COMPD OF MAGNESIUM WITH MIXTURE OF SOLID ORG ACIDS OBTAINED FROM FATS, & CONSISTS CHIEFLY OF VARIABLE PROPORTIONS OF MAGNESIUM STEARATE & MAGNESIUM PALMITATE. IT CONTAINS EQUIVALENT OF 6.8-8.0% OF MAGNESIUM OXIDE (40.30).
GRADES: TECHNICAL, USP FCC.
A TYPICAL DRY COMPRESSED ANTIPERSPIRANT STICK/CONTAINS/0.25 wt% MAGNESIUM STEARATE
불러오는 중…
88.5 °C (pure)
MP: 132 °C /Technical/
88 °C
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. The powder is greasy to the touch and readily adheres to the skin. nonflammable used in baby dusting powder(s) and as tablet lubricant.
No listed effects of short-term or long-term exposure; [ICSC] Mildly toxic by ingestion; [HSDB] May cause irritation; [MSDSonline] See STEARATES.
Substance added directly to human food affirmed as generally recognized as safe (GRAS).
An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning of section 201(s)(4) of the Act is exempt from classification as a food additive. ... Substances classified as stabilizers, when migrating from food-packaging material shall include: magnesium stearate.
Residues of magnesium stearate are exempted from the requirement of a tolerance when used as a surfactant in accordance with good agricultural practices as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest.
Skin Irrit. 2 (22.4%)
Skin corrosion/irritation - Category 3
Fresh air, rest.
First rinse with plenty of water for several minutes (remove contact lenses if easily possible), then refer for medical attention.
Rinse mouth. Rest.
SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.
Residues of magnesium stearate are exempted from the requirement of a tolerance when used as a surfactant in accordance with good agricultural practices as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest.
ACGIH Carcinogen - Not Classifiable.
ACGIH Carcinogen - Not Classifiable.
The CIR Expert Panel concluded that the following ingredients are safe in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating and non-sensitizing, which may be based on a QRA...Magnesium Stearate
Safe for use in cosmetics, with qualifications
Cough.
Vomiting.
/HUMAN EXPOSURE STUDIES/ ...DEATHS HAVE BEEN CAUSED BY ACCIDENTAL INHALATION OF THE /BABY DUSTING/ POWDER, /CONTAINING MAGNESIUM STEARATE/.
/HUMAN EXPOSURE STUDIES/ Slightly toxic by ingestion.
/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ Magnesium stearate was fed to groups of 20 male and 20 female rats at levels of 0, 5, 10 and 20% in a semisynthetic diet for 3 months. Decreased weight gain was found in males in the 20% group. Urolithiasis was found in 8 males and in 7 females in the same group. Reduced relative liver weight was seen in males in the 10% and in the 20% groups, and an increased amount of iron was found in the livers of the 20% group. Nephrocalcinosis was reduced in females in the 20% group. In this experiment the no-effect-level is estimated to be 5% magnesium stearate in the diet, corresponding to 2,500 mg/kg bw/day.
Substance added directly to human food affirmed as generally recognized as safe (GRAS).
An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the meaning of section 201(s)(4) of the Act is exempt from classification as a food additive. ... Substances classified as stabilizers, when migrating from food-packaging material shall include: magnesium stearate.
Residues of magnesium stearate are exempted from the requirement of a tolerance when used as a surfactant in accordance with good agricultural practices as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest.
EPA Safer Chemical Functional Use Classes -> Surfactants
Safer Chemical Classes -> Green half-circle - The chemical is expected to be of low concern
Food Additives -> ANTICAKING_AGENT; EMULSIFIER; Food Additives -> -> JECFA Functional Classes
Cosmetics -> Moisturising; Cosmetic colorant; Anticaking; Bulking
Plastics Material and Resin Manufacturing
Octadecanoic acid, magnesium salt (2:1): ACTIVE
The more important dusting powders include ... magnesium stearate, NF ...
Microspheres containing the mucoadhesive polymer chitosan hydrochloride, with matrix polymer Eudragit RS, pipemidic acid as a model drug and agglomeration preventing agent magnesium stearate were prepared by the solvent evaporation method. The amount of magnesium stearate was varied and the following methods were used for microsphere evaluation: sieve analysis, drug content and dissolution determination, scanning electron microscopy, x-ray diffractometry, DSC and FTIR spectroscopy. The results showed that average particle size decreased with increasing amount of magnesium stearate used for microsphere preparation. This is probably a consequence of stabilization of the emulsion droplets with magnesium stearate. Higher pipemidic acid content in the microspheres was observed in larger particle size fractions and when higher amounts of magnesium stearate were used. It was also found that these two parameters significantly influenced the dissolution rate. The important reason for the differences in drug content in microspheres of different particle sizes is the diffusion of pipemidic acid from the acetone droplets in liquid paraffin during the preparation procedure. The physical state of pipemidic acid changed from crystalline to mostly amorphous with its incorporation in microspheres, as shown by x-ray diffractometry and differential scanning calorimetry. No differences were observed in the physical state of pipemidic acid and in microsphere shape and surface between different size fractions of microspheres, prepared with different amounts of magnesium stearate. Additionally, no correlation between the physical state of the drug in different microspheres and their biopharmaceutical properties was found.
개요Magnesium stearate, also called octa decanoic acid, magnesium salt, is a white substance, powder which becomes 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 be expected in the future.".
용도Magnesium Stearate is the magnesium salt of stearic acid which functions as a lubricant, binder, emulsifier, and anticaking agent. it is a white powder that is insoluble in water. it is used as a lubricant or die release in tableting pressed candies and is also used in sugar- less gum and mints.
일반 설명Magnesium stearate (Mg-St) is the magnesium salt of stearic acid. Its anhydrate, dihydrate and trihydrate forms have been prepared. The tabletting of the blends of magnesium stearate and lactose granules has been described. The influence of mixing time on hardness, disintegration time and ejection force on the compressed tablets was examined. Mg-St is widely used lubricant in pharmaceutical industry. It also plays a role in delaying the process of dissolution. Its detection in tablets by laser-induced breakdown spectroscopy has been proposed.
Magnesium stearate is created by the reaction of sodium stearate with magnesium sulfate.
생산 방법Magnesium 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.
순도시험(1) 납 : 이 품목 5.0g을 취하여 원자흡광광도법 또는 유도결합플라즈마발광광도법에 따라 시험할 때, 그 양은 5.0ppm 이하이어야 한다. (2) 염화물 : 이 품목 5g을 취하여 환저플라스크에 넣고, 과산화물을 함유하고 있지 않은 디에틸에테르 50mL , 묽은질산 20mL 및 물 20mL를 가한 다음, 환류냉각기를 장착하고 완전히 녹을 때 까지 가열한다. 냉각한 다음, 플라스크의 내용물을 분액깔대기에 옮기고 흔들어 섞은 후, 방치하여 수층을 분취한다. 디에틸에테르층을 물 4mL로 2회 추출하여 추출액을 합하고, 디에틸에테르 15mL로 세정한 다음 물을 가하여 정확히 50mL로 한 액을 시험용액으로 한다. 시험용액 10mL를 취하여 염화물시험법에 따라 시험할 때, 그 양은 0.02N 염산 1.4mL에 대응하는 양 이하이어야 한다(0.10% 이하). (3) 황산염 : 순도시험 (2)의 시험용액 10mL를 취하여 황산염시험법에 따라 시험할 때, 그 양은 0.02N 황산 10.2mL에 대응하는 양 이하이어야 한다(1.0% 이하).
확인시험(1) 이 품목 1g에 염산(1→6)을 가하여 가열하고 식힐 때, 상층에는 지방산층이 뜨고 하층의 수용액은 확인시험법 중 마그네슘염의 반응을 나타낸다. (2) 이 품목 25g을 뜨거운 물 200mL와 혼합하고 묽은황산 60mL를 가하고 자주 저어 주면서 투명한 상층액이 분리될 때까지 가열한 다음 황산이온이 없을 때까지 뜨거운 물로 충분히 세척하고 작은 비이커에 옮겨 증기욕상에서 지방산이 투명하게 될 때까지 수분을 분리시키고 방치한 후 물층은 버리고 지방산층은 가열용융하여 여과한 후 105℃에서 20분간 건조시키고 응고점시험법에 따라 시험할 때, 54℃이상이어야 한다.
정량법이 품목 약 1g을 정밀히 달아 0.1N 염산 50mL를 가하고 때때로 물을 보충하면서 30분간 끓인다. 이를 식힌 후 여과하여 여액이 산성이 나타나지 않을 때까지 충분히 씻고 씻은 액을 여액과 합하여 1N 수산화나트륨용액으로 중화한 다음 이를 시험용액으로 하여 0.05M 이.디.티.에이.용액 30mL, 암모니아․염화암모늄완충액 5mL 및 에리오크롬블랙시액 0.15mL를 가하고 액의 색이 청색이 될 때까지 0.05M 이.디.티.에이.용액으로 적정한다.0.05M 이.디.티.에이.용액 1mL = 2.015mg MgO
정의이 품목은 스테아린산 및 팔미틴산의 마그네슘염의 혼합물이다.
정의Mg(C18H35O2)2 or with one H2O. Technical grade contains small amounts of the oleate and 7% magnesium oxide, MgO.