Name | Magnesium Stearate |
Synonyms | Dolomol petracmg20nf MAGNESIUM STEARATE Magnesium Stearate MAGENSIUM STEARATE stearatedemagnesium magnesiumdistearate Magnesium Stearate Bp MAGNESIUM OCTADECANOATE magnesium dioctadecanoate dibasicmagnesiumstearate Magnesiumstearatemedicinal STEARIC ACID MAGNESIUM SALT OCTADECONIC ACID MAGNESIUM SALT Octadecanoic acid magnesium salt OCTADECANOIC ACID MAGNESIUM SALT |
CAS | 557-04-0 |
EINECS | 209-150-3 |
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 |
InChIKey | DRJIJXNWSSRTTE-UHFFFAOYSA-M |
Molecular Formula | C36H70MgO4 |
Molar Mass | 591.24 |
Density | 1.028g/cm3 |
Melting Point | 200 °C (lit.) |
Water Solubility | Insoluble |
Solubility | alcohol: insoluble |
Appearance | White powder |
Color | White |
Exposure Limit | ACGIH: TWA 10 mg/m3; TWA 3 mg/m3 |
Merck | 14,5690 |
BRN | 3919702 |
PH | 7 (H2O) (slurry) |
Storage Condition | Inert atmosphere,Room Temperature |
Stability | Stable. Incompatible with strong oxidizing agents. |
MDL | MFCD00036391 |
Physical and Chemical Properties | color loose fine powder, feel smooth, insoluble in water, ethanol and ether, soluble in hot water, ether, acid decomposition into stearic acid and the corresponding magnesium salt. Solubility in water at room temperature 77-79mg/L, soluble in hot ethanol. In case of acid decomposition into stearic acid and the corresponding magnesium salts. The patient has mild odor and a smooth feeling. |
Use | The product is used as PVC heat stabilizer, and the year of cosmetics flour, emollient ointment and pharmaceutical tablet raw materials (excipients, lubricating medicine); Used in the school Wood powder to make the lubrication bright and transparent; paint industry as a transparent flat agent. The metal soaps used as the polyvinyl chloride stabilizer are mostly higher fatty acid salts of cadmium, barium, calcium, zinc and magnesium, and the base is a salt of stearic acid which is lauric acid. The performance of the metal soap stabilizer varies with the type of metal and the acid radical, and the general rules are as follows: heat resistance: cadmium, zinc soap early heat resistance; Barium, calcium, magnesium, strontium soap long-term heat resistance is good, lead soap in the middle. Weather Resistance: cadmium, zinc, lead, barium, tin soap better. Processability: lead and cadmium soap have good lubricity, but acid radicals also have great influence on lubricity. Widely used in food, medicine, paint, plastic, rubber, textile |
Hazard Symbols | Xi - Irritant |
Risk Codes | 36/37/38 - Irritating to eyes, respiratory system and skin. |
Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S37/39 - Wear suitable gloves and eye/face protection |
WGK Germany | - |
RTECS | WI4390000 |
TSCA | Yes |
HS Code | 29157030 |
Toxicity | LD50 orally in Rabbit: > 2000 mg/kg |
Reference Show more | 1. Liu Wei, Liu Wen, Song Xinli, etc. Preparation and quality evaluation of breviscapine gastric adhesive tablets [J]. China Pharmacy, 2020(14). 2. Wang Guanhua, Liu Wen, Song Xinli, Liu Wei, Wang Yunxia, He Dongbo. Preparation and quality standard of total glucosides of paeony colon-specific tablets [J]. Chinese herbal medicines, 2019,42(11):2622-2626. 3. Du Ping, Liu Wen, Qing Yongjun, Yao Xiaoyan, Jin Yang, Chen huaichen, He Li. Study on compound sustained-release preparation of traditional Chinese medicine based on "drug-assisted combination": a case study of Shaoyao gancao gastric floating tablet [J]. Chinese herbal medicines, 2018,41(10):2403-2407. 4. [IF = 6.321] Xuemei Wen et al."Preparation and In Vitro/In Vivo Evaluation of Orally Disintegrating/Modified-Release Praziquantel Tablets." Pharmaceutics. 2021 Oct;13(10):1567 5. [IF = 5.875] Qi Zeng et al."Solution profiles prediction of sinomenine hydrochloride sustained-release tablets using Raman mapping technique." INTERNATIONAL JOURNAL OF PHARMACEUTICS. 2022 May;620:121743 |
This product is a combination of magnesium and stearic acid. It is a mixture of magnesium stearate (C36H7QMg()4) and magnesium palmitate (c32hs2mg04) as the main components. Calculated as the dried product, the content of M g should be 4.0% ~ 5.0%.
take L. 0 g of this product, add 20.0ml of water, heat on the water bath for 1 min and constantly shake, let cool, filter, take 10.0ml of continued filtrate, add 0.05ml of bromothymol blue indicator solution, with hydrochloric acid titration solution (0.1 mol/L) or sodium hydroxide titration solution (O .lmol/L) drop to the solution color change, the amount of titration solution should not exceed 0.05.
measure 1.0 of the test solution under Item (1) for identification, check according to law (General rule 0801), and compare with the standard gasified sodium solution 10.0ml of the control solution should not be more concentrated (0.10%).
1.0 of the test solution under the item of identification (1) was measured and checked according to law (General rule 0802), and the standard potassium sulfate solution 6. Compared with the control solution made of 0ml, it should not be more concentrated (0 .6%).
take this product, dry to constant weight at 80°C, weight loss shall not exceed 5.0% (General rule 0831).
take 0.50g of this product, burn and ash, add 5ml of dilute hydrochloric acid and 10ml of water, boil, cool, filter, add 50mg of ammonium persulfate to filtrate, dilute to 35ml with water, inspection according to law (General rule 0807), and standard iron solution 5.0ml of control solution prepared by the same method should not be deeper (0.01%).
take two 0.05g aliquots of this product, weigh the amount of precision, place them in the high-pressure digestion tank respectively, add 2ml nitric acid in one aliquot for digestion, transfer them quantitatively to a 100ml measuring flask, and dilute them to the scale with water, shake, as a test solution; Another Precision Plus standard cadmium solution (precise quantity of cadmium single element standard solution appropriate amount, 0.5 of a solution containing 0.3Mg of cadmium per 1 ml was prepared by quantitative dilution with water, and was operated in the same manner as the reference solution. According to Atomic Absorption Spectrophotometry (General rule 0406 second method), the absorbance was measured at the wavelength of 228. 8nm, and the calculation should comply with the provisions (0. 0003%).
take this product 0. Two aliquots of 05G were weighed and placed in a high-pressure digestion tank respectively. After 2ml of nitric acid was added to one aliquot for digestion, the mixture was transferred to a 10ml measuring flask quantitatively, diluted with water to the scale, and shaken well, as a test solution; Another part of the Precision Plus standard nickel solution (precise quantity of nickel single element standard solution appropriate amount, quantitative dilution with water to make a solution containing 0.5 ug of nickel per 1 ml) 0.5ml, the same method of operation, as a reference solution. According to Atomic Absorption Spectrophotometry (General rule 0406 second method), at the wavelength of 232.0nm were measured absorbance, calculation, should comply with the provisions (0005%).
take 2.0g of this product, slowly burn to complete carbonization, cool, add 0.5~1.0 sulfuric acid to wet, heat at low temperature until the sulfuric acid is removed, add 0.5 nitric acid, after evaporation to dryness, after removing the nitrogen oxide vapor, cool down, burn at 500~600°C to make it ash completely, cool down, add 2ml of hydrochloric acid, after being evaporated on a water bath, add 1 5ml of water and 2ml of dilute acetic acid, heat and dissolve, let it cool, add 2M l of acetate buffer (pH 3.5) and an appropriate amount of water to 25ml, inspection according to law (General Principles 0821 second law), containing heavy metals shall not exceed 15 parts per million.
take this product O.lg, precision weighing, set the Erlenmeyer flask, add boron trifluoride methanol solution [take boron trifluoride monohydrate or dihydrate appropriate amount (equivalent to boron trifluoride 14g), add methanol dissolved and diluted to 100ml, add 4ml of n-heptane from the condenser tube and reflux for 10 minutes. After cooling, add 20ml of saturated sodium chloride solution, the n-heptane layer was passed through O with anhydrous sodium sulfate. A glass column of 1g (previously washed with n-heptane) was used as the test solution. Test according to Gas chromatography (General 0521). A capillary column with polyethylene glycol 20m as stationary phase, the initial temperature is 70°C, the temperature is maintained for 2 minutes, the temperature is raised to 240°C at a rate of 5°C per minute, and the temperature of the injection port is 220°C, the detector temperature was 260°C. The appropriate amount of the reference substance of methyl palmitate and methyl stearate was weighed respectively, and the solution containing about 15mg and 10 mg per 1 ml was prepared by adding n-heptane. 1M1 was injected into the gas chromatograph, and the separation degree of methyl palmitate peak and methyl stearate peak should be greater than 3 .0. Accurately measure 1 ml of the test solution, put it in a 100ml measuring flask, dilute it to the scale with n-heptane, shake well, and inject 1ul into the gas chromatograph to adjust the detection sensitivity, the methyl palmitate peak and the methyl stearate peak should be detectable.
This product shall be taken and inspected according to law (General Principles 1105 and 1106). The total number of aerobic bacteria per lg of test product shall not exceed lOOcfu, the total number of mold and yeast shall not exceed lOOcfu, E. Coli should not be detected.
take about 0.2g of this product, precision weighing, add 50ml of n-butanol-anhydrous ethanol (1 : 1) solution, 5ml of concentrated ammonia solution and 3ml of ammonia-ammonium chloride buffer (pHl O.O), then add a small amount of human ethylenediamine tetraacetic acid disodium titration solution (0.05mol/U25ml) and Chrome Black T indicator, mix well, heat on a water bath at 40-50°C until the solution is clear, titrated with zinc titrant (0.05mol/L) until the solution turned from blue to purple, and the titration results were corrected with a blank test. Each 1 ml of ethylenediamine tetraacetic acid disodium titration solution (0.05mol/L) is equivalent to 1. 215Mg of Mg.
pharmaceutical excipients, lubricants.
sealed storage.
EPA chemical substance information | information provided by: ofmpeb.epa.gov (external link) |
Introduction | Magnesium stearate(light) Magnesium stearate(light) project Index chemical formula Mg[C17H35COO]2 appearance white powder, no obvious mechanical impurities. Standard specification Q/CJYF.7-2001 magnesium content,% 6.5~7.7 melting point, ℃ is greater than or equal to 120 free fatty acid (based on stearic acid),% less than or equal to 3.0 heating loss,% less than or equal to 3.0 fineness (through 0.075mm sieve),%≥ 99.0. |
properties | magnesium stearate is a white loose powder, odorless and tasteless, delicate and sand-free, light characteristic aroma. |
uses | The Uses of magnesium stearate are as follows: 1. Magnesium stearate is both a stabilizer and a lubricant for plastics, for example, it is used as an internal and external lubricant in a hard polyvinyl chloride product. 2, in cosmetics as an emulsifier. 3, magnesium stearate is also used as a dry powder extinguishing agent. used as PVC heat stabilizer, ABS, Amino Resin, phenolic resin and urea-formaldehyde resin lubricants, paint additives used in the system of perfume powder, cosmetics, it is also used as a drying agent anti-caking agent for paints and pseudo-paints; A mold release agent; An emulsifier. The product is used as PVC heat stabilizer, and year of cosmetics flour, emollient ointment and pharmaceutical tablet raw materials (excipients, lubricating medicine); Used in the school Wood powder to make the lubrication bright and transparent; paint industry as a transparent flat agent. The metal soaps used as the polyvinyl chloride stabilizer are mostly higher fatty acid salts of cadmium, barium, calcium, zinc and magnesium, and the base is a salt of stearic acid which is lauric acid. The performance of the metal soap stabilizer varies with the type of metal and the acid radical, and the general rules are as follows: heat resistance: cadmium, zinc soap early heat resistance; Barium, calcium, magnesium, strontium soap long-term heat resistance is good, lead soap in the middle. Weather Resistance: cadmium, zinc, lead, barium, tin soap better. Processability: lead and cadmium soap have good lubricity, but acid radicals also have great influence on lubricity. For the same metal, the aliphatic is better than the aromatic, and the longer the molecular chain in the aliphatic acid group, the better the lubricity. Barium, calcium, magnesium, strontium soap lubrication is poor, but the Gelation can be good. Pressure: barium, calcium, magnesium, strontium soap is easy to produce pressure phenomenon, and zinc, cadmium, lead soap is not easy to occur pressure, the longer the molecular chain of fatty acid soap, the sub-weight of pressure precipitation, the more harmful the frost spray. Lead and cadmium soap are highly toxic, Sulfide contamination. In the non-toxic formula, calcium, zinc soap is used; In the resistance to sulfide pollution, barium, zinc soap is used. Magnesium stearate can be regarded as non-toxic, the United States, Germany and Japan allow for contact with food-based products, but as a heat stabilizer for polyvinyl chloride is not widely used. In China's pharmacopoeia and some other national Pharmacopoeia contains this species, the pharmacopoeia of magnesium content, moisture, heavy metals, iron, sulfate and chloride content are prescribed. The product is used as PVC heat stabilizer, and year of cosmetics flour, emollient ointment and pharmaceutical tablet raw materials (excipients, lubricating medicine); Used in the school Wood powder to make the lubrication bright and transparent; paint industry as a transparent flat agent. The metal soaps used as the polyvinyl chloride stabilizer are mostly higher fatty acid salts of cadmium, barium, calcium, zinc and magnesium, and the base is a salt of stearic acid which is lauric acid. The performance of the metal soap stabilizer varies with the type of metal and the acid radical, and the general rules are as follows: heat resistance: cadmium, zinc soap early heat resistance; Barium, calcium, magnesium, strontium soap long-term heat resistance is good, lead soap in the middle. Weather Resistance: cadmium, zinc, lead, barium, tin soap better. Processability: lead and cadmium soap have good lubricity, but acid radicals also have great influence on lubricity. Widely used in food, medicine, coatings, plastics, rubber, textile and other stabilizer; Lubricant; Pharmaceutical tablet raw materials is a new type of pharmaceutical excipients, can be used as film-forming coating materials for solid preparations, thickening agent and suspension agent of colloidal liquid preparation |
surfactant | magnesium stearate, also known as magnesium stearate, is a fatty acid salt Type Anionic Surfactant with white fine powder appearance, the patient has mild odor and a smooth feeling. Soluble in thermal aliphatic hydrocarbons, thermal aromatic hydrocarbons, thermal oils and fats, but insoluble in alcohol and water, in case of strong acid decomposition into stearic acid and the corresponding magnesium salts. Magnesium stearate has good adhesion to the skin, good lubricity, in cosmetics for powder products, can improve adhesion, lubrication. magnesium stearate can be used as a heat stabilizer for polyvinyl chloride, and its stabilizing effect is similar to that of calcium stearate. It can be used in food packaging materials with zinc soap or calcium soap, but it is not widely used. magnesium stearate can also be used as a mold release agent for plastic products, a raw material for cosmetic powder, a moisturizing ointment, a powder molding agent for pharmaceutical tablets, and a translucent leveling agent for paint. The finished product of magnesium stearate was prepared by metathesis reaction of sodium stearate and magnesium sulfate in the laboratory. It can also be refined from the mixture of food-grade solid organic acid (stearic acid, palmitic acid) and magnesium oxide. |
content analysis | accurately weigh about lg of sample, add 0.1mol/L hydrochloric acid 50ml, boil for about 30min, or, until the precipitated fatty acid layer is clarified, water is added to the original volume if necessary. It was cooled, filtered, and the filter and filter residue were rinsed with water until the eluate was not acidic to The Litmus. The filtrate was neutralized with 1mol/L sodium hydroxide to Neutral litmus. With full stirring of magnetic stirrer, titrate with 0.05mol/L ED] limiting disodium as follows: Add 30ml of titration solution from a 50ml burette, and then add ammonia/potassium chloride buffer solution (TS-12). 5ml and wool Chrome Black test solution (TS-97)0.15ml, then continue titration to Blue endpoint. Per mL of 0.05mol/L of ED-TA disodium solution is equivalent to MGO 2.015mg. |
toxicity | ADI unlimited regulation (FAO/WHO,2001). GRAS(FDA,§ 184.1440,2000). |
usage limit | FAO/WHO(g/kg): coating with glucose powder and sugar cane sugar powder 15 (no starch); Soup 15.GB 2760-2001: pectin base, candy, GMP Limited; Preserved fruit 0.8g/kg. |
production method | sodium stearate is obtained by saponification of stearic acid with sodium hydroxide and then metathesis with magnesium sulfate to obtain magnesium stearate. Stearic acid and water were added to the reaction Pan, heated to 85 °c, stirred and dissolved, and then sodium hydroxide solution preheated to 75 °c was slowly added. After completion of the saponification reaction, the temperature was controlled at 72 °c, and a magnesium sulfate solution preheated to 55 °c was slowly added with stirring. After the double decomposition, the filter cake was washed with water until the sulfate group met the requirements, and then dried, air dried and sieved to obtain the finished product. The yield of p-stearic acid was 100%. Raw material consumption (kg/t) stearic acid (industrial) 960 sodium hydroxide (95%) 140 magnesium sulfate (98%) 410 mixed fatty acids from magnesium oxide and food-grade solid (mainly stearic acid) the compound was refined. |
toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |