Product Detail
Basic Info
Model NO.:M-2
Type:Mannitol
Nutritional Value:Nutritional
Effect:Stabilization
Resource:Natural
Product Description
Specifications
1.white cyrstalline powder
2. BP2007/USP Standard
3.pharma grade
Mannitol
Molecular formula: C6H14O6
Molecular weight: 182.17
Capacity: 10000MT/YEAR
package: 25KG KRAFT/BAG 25KG/DRUM
Characteristics:
The product is colorless crystalline powder, odor free and with sweet taste, it is easily dissolved in water and slightly sissolved in ethyl alcohol.
Application:
Injection material: used in producing the mannitol injection solution, reducing the encephalic pressure, the intraocular pressure etc.
Excipient of filler for tablets: used in the anticancer drug, antibacterial, antihistamine medicine, in vitamin, drunk awaking 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: 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.
CERTIFICATE OF ANALYSIS
Commodity | Mannitol | Batch NO | 1009083 | |
Packing | 25kg / bag | MFG. date | Sep.3.2010 | |
Quantity | 10000kg | Expiry date | Sep.2.2012 | |
Basis | Correspond to BP2007 | |||
ITEM | STANDARD | RESULT | CONCLUSION | |
Appearance | White crystalline powder | White crystalline powder | Conformity | |
Identification A: Infrared absorption spectrophotometry | Conformity | Conformity | Conformity | |
Identification B: Melting point | 165°C~170°C | 165.9°C~167.9°C | Conformity | |
Identification C: TLC | Conformity | Conformity | Conformity | |
Identification D: Specific optical rotation | +23°~ +25° | +23.3° | Conformity | |
Appearance of solution | Clear and colourless | Clear and colourless | Conformity | |
Conductivity | ≤20us/cm | 4.9us/cm | Conformity | |
Reducing sugars | ≥12.8 ml | 17.7ml | Conformity | |
Related substances: The area of any peak Total impurities | ≤2% ≤2% | <2% <2 % | Conformity | |
Lead | ≤0.5 ppm | <0.5 ppm | Conformity | |
Nickel | ≤1 ppm | <1 ppm | Conformity | |
Loss on drying | ≤0.5% | 0.2% | Conformity | |
Microbial contamination: TAMC TYMC Escherichia coli Salmonella | ≤100 CFU/g ≤100 CFU/g Negative Negative | <10 CFU/g <10 CFU/g Negative Negative | Conformity | |
Bacterial endotoxins | <2.0EU/g | <2.0 EU/g | Conformity | |
Assay | 98.0% ~ 102.0% | 99.6% | Conformity | |
Remark | Samples | |||
Conclusion | Conformity | |||