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.
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.
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.
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.
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.
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. | ||
| 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) | 1.A white crystalline precipitate is produced.2.A bright red turbidity develops which gradually settles 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% | |
| 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 | 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.
Uses & Applications
Magnesium stearate has been used as an emulsifier, binder, and thickener, as well as an anticaking, lubricant.
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.
Magnesium stearate present in many food supplements, confectionery, chewing gum, herbs and spices, and baking ingredients
Properties
| Molecular formula | C36H70MgO4 |
| Molar mass | 591.27 g/mol |
| IUPAC name | Magnesium octadecanoate |
| CAS number | 557-04-0 |
Packaging Details
Available Packaging Type:
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
Packaging Details
Available Packaging Type:
1. HDPE/Paper bags – 25Kg
1. Fiberboard/HDPE – 25Kg
*Our standard packaging in 25 Kg bags. We can also customize packaging as per customers request at additional cost
Frequently Asked Questions
What is magnesium stearate, and how is it used as a pharmaceutical excipient?
Magnesium stearate, a magnesium salt of stearic acid, serves as a crucial pharmaceutical excipient valued for its lubrication and uniformity properties.
What is Ankit Pulps and Boards' role in the manufacturing and supply of magnesium stearate?
Our magnesium stearate comply with highest pharmaceutical standards with prompt efficacy. Using Premium quality raw material & 100% vegetable origin Stearic acid for better specific surface area & lubrication
How does Ankit Pulps and Boards ensure the quality and purity of its magnesium stearate products?
At Ankit Pulps and Boards, we prioritize the quality and purity of our magnesium stearate products. Our manufacturing facility is entirely automated, ensuring a streamlined and efficient process that adheres to the highest standards of quality. We conduct regular testing and inspection of raw materials, in-process samples, and finished goods to maintain the integrity and purity of our magnesium stearate.
Are Ankit Pulps and Boards' magnesium stearate products compliant with relevant pharmacopeial standards, such as USP and EP?
Yes, we have FDA approved inhouse R&D Lab and 100% compliant to regulatory standards.
How can I request samples of Ankit Pulps and Boards' magnesium stearate for evaluation in our pharmaceutical formulations?
Please share enquiry/sample request on sales@celluloseankit.com
Does Ankit Pulps and Boards provide technical support and guidance for optimizing the use of magnesium stearate in pharmaceutical formulations?
Absolutely! Our proficient technical team is at your service to provide comprehensive support and guidance, ensuring the optimal use of magnesium stearate in your pharmaceutical formulations. We are committed to meeting your customization needs with expertise and precision.
What are the recommended storage conditions and shelf life for Ankit Pulps and Boards' magnesium stearate products?
It is recommended to store our magnesium stearate as per pharmacopoeial standards, ensuring optimal conditions. The shelf life of our products is 5 years from the manufacturing date.
What is the purpose of magnesium stearate in a drug formulation?
The primary purpose of magnesium stearate in a drug formulation is to ensure uniformity, quality, and smooth compression during the manufacturing process.
What is Magnesium Stearate, and how is it used in the food industry?
Magnesium Stearate is a magnesium salt of stearic acid primarily used in the food industry for its lubrication and thickening properties.
What are the typical applications of Magnesium Stearate in food products?
Magnesium Stearate is commonly used in food products to enhance texture, soothing and emulsifying of the product.
Is Magnesium Stearate safe for consumption, and is it approved by regulatory authorities for use in food products?
The FDA has approved magnesium stearate for use as an additive in food and supplements.
How does Magnesium Stearate contribute to food product quality and shelf life?
Magnesium Stearate contributes as emulsifier, binder and thickener, anticaking, lubricant and antifoaming agent which ultimately improves quality and shelf life.
Are there specific labeling requirements for food products containing Magnesium Stearate?
Food grade labelling can be provided as per requirement