Mannitol BP/USP/EP Injection grade
Application: Mannitol is colorless crystalline powder, odor free and with sweet taste, it is easily dissolved in water and slightly dissolved in ethyl alcohol.
Standard: BP/USP,E421
CAS.NO.: 69-65-8
Brand: TianLi, Huaxu, Brightmoon
HS CODE: 290543
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Mannitol Brief Description
Appearance:white crystalline powder
packing :25kg/bags
Shelf Life:2 years
Mannitol is colorless crystalline powder, odor free and with sweet taste, it is easily dissolved in water and slightly dissolved in ethyl alcohol.
Product Specification Of Mannitol FCC/USP
| Items | Standards | ||
| Assay % | 97-102 | ||
| Appearance | White or almost white crystals or powder | ||
| Solubility | Freely soluble in water,practically insoluble in ethanol (96 per cent). | ||
| Specific Optical Rotation | +23°~ +25° | ||
| Melting Point | 165.0℃~170.0℃ | ||
| Infrared Absorption | Conforms | ||
| Appearance of solution | Clear and colorless | ||
| Conductivity | ≤20μS/cm | ||
| Reducing Sugars | ≤0.1% | ||
| A Sorbitol(Disregard limit≤0.05%) | ≤2.0% | ||
| B+C Maltitol+Isomalt | ≤2.0% | ||
| Unspecified | ≤0.1% | ||
| Total(A+B+C+Unspecified) | ≤2.0% | ||
| Nickel | ≤1ppm | ||
| Heavy Metals | ≤5ppm | ||
| Loss on Drying | ≤0.5% | ||
| TAMC | ≤1000cfu/g | ||
| Total Germs | 3000 cfu/g Max | ||
| Molds and Yeast | 100 cfu/g Max | ||
| E. Coli | Negative | ||
| Salmonella | Negative | ||
| Bacterial Endotoxins | <2.5IU/g |
Conclusion: Comply with BP /USP/EP Requirements.
Mannitol Application
1. Injection material: used in producing the Mannitol injection solution, reducing the encephalic pressure, the intraocular pressure etc.
2. Excipient of filler for tablets: used in the anticancer drug, antibacterial, antihistamine medicine, in vietmin, drunk awaking drug, the mouth freshener tablet and so on.
3. Vasodilator medicine for blood vessel of brain: used in treating the blood vessel blocked brain.
4. Diuretic stuff: mannitol is a kind of mild laxative lapactic, which has a special curative effect to oliguria and the kidney function failure caused by dropsy, burnt and so on.
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