Magnesium Stearate, Dolomol, magnesium distearate, MAGNESIUM OCTADECANOATE, magnesium diocta decanoate, dibasic magnesium stearate, OCTADECANOIC ACID MAGNESIUM SALT, 557-04-0

Magnesium Stearate, Dolomol, magnesium distearate, MAGNESIUM OCTADECANOATE, magnesium diocta decanoate, dibasic magnesium stearate, OCTADECANOIC ACID MAGNESIUM SALT, 557-04-0

CAS: 557-04-0

Molecular Formula: C36H70MgO4

Names and Identifiers

Physico-chemical Properties

Risk and Safety

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

Upstream Downstream Industry

Standard

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%.

Trait

• This product is a white and easy sand-free fine powder; Micro-odor; Contact with the skin has a smooth feeling.
• This product is insoluble in water, ethanol or ether.

Introduction

Feeling smooth, insoluble in water, ethanol and ether, soluble in hot water, hot ethanol, acid decomposition into stearic acid and the corresponding magnesium salt. It's irritating.

Differential diagnosis

1. Take 5.0g of this product, put it in a round-bottom flask, add 50ml of peroxide-free diethyl ether, 20ml of dilute nitric acid and 20ml of water, heat to reflux until it is completely dissolved, let it cool, and move it to a separatory funnel, shake, place the layers, move the water layer into another separatory funnel; Extract the ether layer twice with water, 4ml each time, combine the water layer; Wash the water layer with 15ml peroxide-free ether, move the water layer to a 50ml measuring flask, add water to dilute to the scale, shake well, and use as a test solution to identify the reaction of magnesium salt (General rule 0301).
2. in the chromatogram recorded under the check item of the relative contents of stearic acid and palmitic acid, the retention times of the two main peaks in the chromatogram of the test solution should be respectively consistent with the retention times of the two main peaks of the control solution.

Exam

pH

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.

chloride

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%).

sulfate

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%).

loss on drying

take this product, dry to constant weight at 80°C, weight loss shall not exceed 5.0% (General rule 0831).

Iron Salt

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%).

cadmium salt

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%).

nickel salt

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%).

Heavy metals

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.

relative content of stearic acid and palmitic acid

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.

microbial limit

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.

Content determination

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.

Category

pharmaceutical excipients, lubricants.

Storage

sealed storage.

Reference Information