Mannitol: An Excellent Excipient For Pharmaceutical Industry
Mannitol is a colorless low-calorie-based sugar alcohol. A biological system such as the intestines takes lots of time to absorb this low-calorie sweetener. An osmotic & duration component, which naturally exists in fruits and vegetables, boosts the osmolality of blood plasma. Therefore, as an antiglaucoma agent-based medication, Mannitol injection is prescribed by doctors.
The natural sources of Mannitol are brown algae, fresh button mushrooms, tree bark, fruits including watermelon, snow peas, peaches, prunes, pears & vegetables like sweet potato, celery, etc. Mannitol has become popular in the pharmaceutical and food manufacturing industries as an essential biochemical component. The global market value of Mannitol increases annually.
The industrial manufacturing unit executes the chemical hydrogenation process to extract a pure version of Mannitol. The combination of 50% fructose and 50% glucose syrup is treated under high pressure and high temperature. In this biochemical treatment, the catalyst – Raney Nickel turns B-fructose into pure Mannitol through hydrogenation.
We use pure fructose to produce a new version of Mannitol through chemical hydrogenation. But, the chemical hydrogenation of fructose is always an expensive treatment. So, few manufacturing units opt for the microbes-driven biotechnological methodology to produce Mannitol to meet the requirements of industrial applications.
Alongside the chemical hydrogenation process, Mannitol can be produced through the microbial fermentative process.
In the gum and candy manufacturing industry, Mannitol is used in versatile ways. This is one of the safe sugar fructose, which works best as capsule diluent, excipient in chewable tablets, etc. It is a safe bulking agent that does not elevate blood sugar levels. Therefore, in the food industries, manufacturing units use Mannitol as a sweetener, which is safe for diabetic patients. Besides, the excellent binding efficiency makes Mannitol one of the best choices as an excipient in medical formulations.
| Test | USP | BP | IP |
| Description / Appearance | White, crystalline powder or free-flowing granules. | White or almost white crystals or powder. | A white, crystalline powder or free flowing granules. |
| Solubility | Freely soluble in water; soluble in alkaline solutions; slightly soluble in pyridine; very slightly soluble in alcohol; practically insoluble in ether. | Freely soluble in water, practically insoluble in ethanol (96%). | Freely soluble in water; slightly soluble in pyridine; very slightly soluble in ethanol (95%); insoluble in chloroform and in ether. |
| Identification Test – A ( Infrared Spectroscopy ) | Should be comply | Should be comply | |
| Identification Test – A (Specific optical rotation) | + 23 to + 25 | ||
| Test – B (Melting point) | 165 °C to 170 °C. | ||
| Test – C – (Infrared spectrophotometry) | Should comply | ||
| Test – D (TLC) | The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a). | ||
| Test – B | A clear solution is obtained which remains clear on the further addition of sodium hydroxide solution. | ||
| Test – C | A pink colour is produced. | ||
| Test – D (Melting range) | 165°C to 170°C. | ||
| Assay | 97.0% – 102% | 97.0% – 102% | 97.0% – 102% |
| Related substances (By liquid chromatography) | |||
| Impurity A | NMT 2.0 % | Not more than 2.0% | |
| Impurity B & C | NMT 2.0 % | Not more than 2.0% | |
| Unspecified impurities | NMT0.10 % | Not more than 0.10% | |
| Total impurities | NMT 2.0 % | Not more than 2.0% | |
| Reducing sugars | NMT 0.1% (3.2ml of 0.02M potassium permanganate required to change green colur to pink) | Max 0.1% | |
| Acidity or alkalinity | NMT 0.3 ml of 0.01 M HCL is required to change the colour of the solution to red. | ||
| Specific optical rotation | +23.0° to +25.0° | ||
| Arsenic | NMT 2 ppm | ||
| Chlorides | NMT 50 ppm | ||
| Sulphates | NMT 100 ppm | ||
| Reducing sugars | NLT 12.8 ml of 0.05 M sodium thiosulphate is required |
||
| Sulphated ash | NMT 0.1% | ||
| Sorbitol | Any spot corresponding to sorbitol in the chromatogram obtained with the test solution is not more intense than the spot in the chromatogram obtained with the reference solution. | ||
| Nickel | NMT 1 µg/g | Max 1 ppm | |
| Melting range | 165° – 170° on the label |
165 °C to 170 °C. | |
| Disregard limit | Not more than 0.05% | ||
| Appearance of solution | The Sample solution is clear and colorless; its clarity is the same as that of water, or its opalescence is not more pronounced than that of the Reference suspension, and it is not more intensely colored than the Standard solution. | The solution is clear and colourless | Solution A is clear and colourless |
| Loss on drying | NMT 0.5% | Max 0.5% | NMT 0.5% |
| Conductivity | NMT 20 µS/cm at 25⁰ C | Max 20 µS.cm-1 |
Microbiological analysis
| Total Aerobic Microbial Count, CFU/g | NMT 1000 | NMT 1000 | NMT 1000 |
| Total Combined Yeasts & Molds Count, CFU/g | NMT 100 | NMT 100 | 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 |
| Bacterial endotoxin test | <2.5IU/g | <2.5IU/g | < 2.5 EU/g |
Uses & Applications
Mannitol is a sugar alcohol (polyol) that finds various uses in both the pharmaceutical and food industries due to its unique properties. Here are some of its applications:
Pharmaceutical Industry:
1.Mannitol used as an excipient in pharmaceutical formulations. It can be used as a bulking agent, diluent, or filler in tablets, capsules, and other solid dosage forms. Its low calorific value makes it suitable for use in sugar-free and reduced-calorie formulations.
Food Industry:
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- Sweetener and Sugar Substitute: Mannitol used as a sugar substitute in sugar-free and reduced-calorie foods.
- Chewing Gum and Confections: Mannitol is having cooling and refreshing properties make it a popular ingredient in sugar-free chewing gums and mints. It imparts a pleasant taste and texture to these products.
- Functional Ingredient: Mannitol is used as a bulking agent and texture enhancer in various food products, including baked goods, confections, and desserts. It can help improve the texture, mouthfeel, and stability of these products.
- Coating Agent: Mannitol is used in the food industry as a coating agent for candies and pills. It helps prevent sticking and provides a smooth, glossy appearance to the coated items.
- Stabilizer and Anti-Caking Agent: Mannitol can be used as a stabilizer in dairy products and as an anti-caking agent in powdered products to prevent clumping.
Properties
| Molecular formula | C6H14O6 |
| Molar mass | 182.17 g/mol |
| Synonyms | D-mannitol. Mannite. |
| CAS number | 69-65-8 |
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 |
Frequently Asked Questions
Our Mannitol comply with highest pharmaceutical standards with prompt efficacy.
We ensure our quality as we are having entirely automated facility, thereby adhering finished product quality.
We have FDA approved inhouse R&D Lab and 100% compliant to regulatory standards.
You are just a click away- please share enquiry/sample request on sales@celluloseankit.com.
Absolutely! Our proficient technical team is at your service to provide comprehensive support and guidance, ensuring the optimal use of mannitol in your pharmaceutical formulations. We are committed to meeting your customization needs with expertise and precision.
It is recommended to store our mannitol as per pharmacopoeial standards, ensuring optimal conditions. The shelf life of our products is 5 years from the manufacturing date.
Mannitol is widely used as coating agent, in sugarfree or reduced calorie formulation.
Mannitol has good cooling and refreshing properties which makes it best for chewable tablets and lozenges.
Mannitol being a versatile sweetener can be used with other excipients without affecting blood sugar levels.
Advantages of using mannitol as a diluent are its excellent compatibility, compactability and higher intrinsic dissolution rate.