Mannitol is widely used as an osmotic diuretic and pharmaceutical excipient in injectable, oral, and solid dosage formulations.
Mannitol is widely used as pharmaceutical excipient, osmotic diuretic and raw material for injection formulations.
| Chemical Name | Mannitol |
|---|---|
| CAS Number | 87-78-5 |
| Molecular Formula | C6H14O6 |
| Molecular Weight | 182.17 |
| Molecular Structure | |
| Storage | Store in a cool, dry place; protect from light; keep tightly sealed. |
| Application | It can be used for injection solutions and large-volume infusions, and can also be used as a diuretic. Due to its compressibility, it also can be use as pharmaceutical excipient. |
| Items | Specifications |
| Appearance | White or almost white crystals or powder |
| Identification: Infrared absorption spectrophotometry | Conformity |
| Assay | 97.0% ~ 102.0% |
| Related substances | Sorbitol≤2.0% Sum of Maltitol and Isomalt ≤2.0% Unspecified impurities ≤0.10% Total impurities ≤2.0% |
| Reducing sugars | ≤0.1% |
| Nickel | ≤1μg/g |
| Melting point | 165 °C ~ 170 °C |
| Appearance of solution | Clear and colourless |
| Loss on drying | ≤0.5% |
| Conductivity | ≤20μS/cm |
| Microbia contamination | TAMC≤103 CFU/g TYMC≤102 CFU/g Absence of Escherichia coli |
| Bacterial endotoxins | ≤2.5 IU/g |
| Residual solvents | The raw materials, manufacturing process and product do not contain any of the solvents listed in Residual Solvents (USP<467>) |
* The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The users are suggested to select the suitability of the products and methods of application.
Used in the production of tablets, capsules, and oral solutions.
Suitable for processing into sterile injectable formulations.
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