Magnesium Stearate
What Is Magnesium Stearate?
Magnesium Stearate is a combination salt that contains two significant compounds magnesium mineral & saturated stearic fatty acid. Both compounds, Magnesium mineral ions & Steareate molecules of saturated stearic fatty acids, create Magnesium Stearate.
How Is Magnesium Stearate Used In Pharmaceutical Industry?
As a solid chemical substance, Magnesium Stearate plays a vital role as a powerful lubricant in processing nutritional supplements. This synthetic substance creates a sustainable layer around the supplement ingredients to decrease the possibility of clumping in the encapsulating equipment.
The humidity level in surrounding manufacturing units’ environments affects the formulation of chewable tablets. To regulate the effects of humidity levels on the chewable tablet manufacturing process, the chemists opt for a well-researched chemical compound, Magnesium Stearate. The strong lubricant properties of Magnesium Stearate enhance the blending capability of the powder and tablet properties.
Therefore, pharmaceutical manufacturing owners prefer to apply Magnesium Stearate as filler binders to win the challenges of fluctuating humidity levels during tablet processing.
Sources of Magnesium Stearate
The saturated fat chain in various plant-based pulps is the source of Magnesium Stearate. Alongside, the compounds of Magnesium Stearate are available in eggs, beef, salmon, etc.
Extensive Roles of Magnesium Stearate In Manufacturing Industries
As a popular synthetic chemical compound, Magnesium Stearate plays a safe & texture-enhancing role in different formulations of pharmaceutical industries, as well as dietary supplements & cosmetic industries.
At average room temperature, Magnesium Stearate behaves as an inactive ingredient in the form of lightweight white powder. But in the manufacturing processes of the cosmetic industry, this powder plays an essential role as an efficient colorant in the formulations of lipsticks, eyeshadows, mascara, deodorants, blushers, face powders, etc.
The Japanese government & WHO Expert Committee on the safety of food additives research claim that Magnesium Stearate does not emerge any genotoxic risk factors when it enters the human body through different processed foods & dietary supplements.
Test |
USP | BP | IP | |
| Description | Very fine, light, white powder, slippery to touch | White or almost white, very fine, light powder, greasy to the touch |
A very fine, light, white powder; odourless or with a very faint odour of stearic acid; unctuous and free from grittiness. |
|
| Solubility | Insoluble in water, alcohol, and ether. | Practically insoluble in water and in anhydrous ethanol. | Practically insoluble in water, in anhydrous ethanol and in ether | |
|
Identification Test – A (Magnesium) |
A white, crystalline precipitate, which is insoluble in 6 N ammonium hydroxide, is formed. | – | – | |
|
Identification Test – B
|
The retention times of the peaks corresponding to stearic acid and palmitic acid of the sample solution correspond to those of the System suitability solution, as obtained in the test for Relative Content of Stearic Acid and Palmitic Acid. | – | – | |
| Test – A Freezing Point | – | Min. 53°C. | NLT 53°. | |
| Test – B Acid Value | – | 195 to 210 | 195 to 210. | |
| Test – C | – |
The 2 principal peaks in the chromatogram obtained with the test solution are similar in retention time to the 2 principal peaks in the chromatogram obtained with the reference solution. |
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| Test – C( Fatty acid composition) | – | – | The principal peaks in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution. | |
| Test – D | – | A white crystalline precipitate is formed. | – | |
| Test – D (Reaction of Magnesium) | – | – |
to give a bright red precipitate. |
|
| Appearance of solution | – | – | Solution A is not more intensely coloured than reference solution YS6. | |
| Appearance of solution of the fatty acids | – | – | The solution is clear, and not more intensely coloured than reference solution YS5. | |
| Assay | NLT 4.0% and NMT 5.0% of magnesium (Mg), | – | Magnesium Stearate contains not less than 3.8% and not more than 5.0% of Mg calculate on the dried basis. | |
| Magnesium | – | 4.0% to 5.0% (dried substance) | – | |
| Stearic acid | – | NLT 40.0% | NLT 40.0% | |
| Sum of stearic acid and palmitic acid | – | NLT 90.0% | NLT 90.0% | |
| Chloride | NMT 0.1 % | Max. 0.1 % | NMT 250 ppm | |
| Sulfate | NMT 1.0% | Max. 1.0% | NMT 0.6% | |
| Limit of Cadmium | NMT 3 ppm | Max 3 ppm | – | |
| Limit of Lead | NMT 10 ppm | Max 10 ppm | – | |
| Limit of Nickel | NMT 5 ppm | Max 5 ppm | – | |
| Zinc Stearate | – | – | No violet precipitate is formed | |
| Free stearic acid | – | – | NMT 3.0% | |
| Heavy Metals | – | – | NMT 20 ppm | |
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Acidity OR Alkalinity
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NMT 0.05 mL of 0.1 N hydrochloric acid or 0.1 N sodium hydroxide is required to change the colour of the indicator. | Not more than 0.05 mL of 0.1 M hydrochloric acid or 0.1 M sodium hydroxide is required to change the colour of the indicator. | NMT 0.05 ml of 0.1 M HCl or 0.1 M NaOH is required to change the colour of the solution. | |
| Acid value of the fatty acids | – | – | Acid value of the fatty acids 195 to 210 | |
| Specific Surface Area | NLT 5.0 m2/g | NLT 5 m2/g | – | |
| Loss on Drying | NMT 6.0% | Max 6.0% | NMT 6.0% | |
| Relative Content of Stearic Acid and Palmitic Acid. | NLT 40% for the stearate peak. The sum of the stearate and palmitate peaks is NLT 90% of the total peak areas of all the fatty acids. | – | – | |
| Microbial limit test | ||||
| Total Aerobic Microbial Count, CFU/g | NMT 1000 | NMT 1000 | NMT 1000 | |
| Total Combined Yeasts & Molds Count, CFU/g | NMT 500 | NMT 500 | NMT 100 | |
| Staphylococcus aureus, / g | Should be absent | Should be absent | Should be absent | |
| Pseudomonas aeruginosa, / g | Should be absent | Should be absent | Should be absent | |
| Escherichia coli, / g | Should be absent | Should be absent | Should be absent | |
| Salmonella, /10g | Should be absent | Should be absent | Should be absent | |
| Shigella,/ 10g | – | – | Should be absent | |
| Bulk Density | 0.15 to 0.30 g/cc | 0.15 to 0.30 g/cc | 0.15 to 0.30 g/cc | |
| Particle Size Distribution | NLT 95% passing through 200 # | NLT 95% passing through 200 # | NLT 95% passing through 200 # | |
| Test | USP | BP | IP |
|---|---|---|---|
| Description | Very fine, light, white powder, slippery to touch | White or almost white, very fine, light powder, greasy to the touch | A very fine, light, white powder; odourless or with a very faint odour of stearic acid; unctuous and free from grittiness. |
| Solubility | Insoluble in water, alcohol, and ether. | Practically insoluble in water and in anhydrous ethanol. | Practically insoluble in water, in anhydrous ethanol and in ether |
| Identification Test – A (Magnesium) | A white, crystalline precipitate, which is insoluble in 6 N ammonium hydroxide, is formed. | – | – |
Magnesium stearate is the magnesium salt of the fatty acid, stearic acid and chemical formula Mg(C17H34COO)2.
- Magnesium stearate has been used as an emulsifier, binder, and thickener, as well as an anticaking, lubricant,.
- Magnesium stearate present in many food supplements, confectionery, chewing gum, herbs and spices, and baking ingredients
- Magnesium stearate is widely used in the production of dietary supplement and pharmaceutical tablets, capsules and powders as well as many food products, including a variety of confectionery, spices and baking ingredients.
| Molecular formula | C36H70MgO4 |
| Molar mass | 591.27 g/mol |
| IUPAC name | Magnesium octadecanoate |
| CAS number | 557-04-0 |
Packaging Details
Available Packaging Type
| Type | Size |
|---|---|
| HDPE/Paper bags | 25Kg |
| Fiberboard/HDPE | 25Kg |
*Our standard packaging in 25 Kg bags. We can also customize packaging as per customers request at additional cost
| Container | Palletized | Non-Palletized |
|---|---|---|
| 20 Ft. (Approx Wt.) | 10,000 Kg | 11,000 Kg |
| 40 Ft. (Approx Wt.) | 20,000 Kg | 25,000 Kg |