Mannitol BP/USP
ITEM | STANDARD |
Appearance | White crystalline powder |
Identification A: Specific optical rotation | +23°~ +25° |
Identification B: Melting point | 165℃~170℃ |
Identification C: Infrared absorption spectrophotometry | Conformity |
Identification D: TLC | Conformity |
Appearance of solution | Clear and colourless |
Conductivity | ≤20us/cm |
Reducing sugars | ≥12.8 ml |
Related substances: Sorbitol Maltitol Isomalt Unspecified impurities Total impurities |
≤2.0% ≤2.0% ≤2.0% ≤0.10% ≤2.0% |
Lead | ≤0.5 ppm |
Nickel | ≤1 ppm |
Loss on drying | ≤0.5% |
Microbial contamination: TAMC TYMC Escherichia coli Salmonella |
≤100 CFU/g ≤100 CFU/g Negative Negative |
Bacterial endotoxins | <2.5 IU/g |
Assay | 98.0% ~ 102.0% |
Mannitol is one kind of hexan-hexol, has the sweet taste. Due to endothermic when dissolves，a comfortable feeling of oral，it is more widely used in chewable tablets manufacture as awaking-yeast medicine、mouth refreshing agent and so on. a particle type is used specifically as direct compression tablets excipients，Mannitol can be used as base material of nitroglycerin tablets and so on medicines .
Role,purpose
Injection material,used in producing the mannitol injection solution，reducing the encephalic pressure、the intraocular and diuretic therapy etc.Excipient of filler for tablets:used in the anticancer drug,antibacterial,antihistamine medicine,in Vitamin,drunkawaking drug,the mouth freshener tablet and so on.Vasodilator medicine for blood vessel of brain:used in treating the blood vessel blocked of brain.Diuretic stuff。the mannitol is one kind of temperate laxative, has the special curative effect. to dropsy,、the burn and so on causes oliguria and the kidney function decline。
