| ≥1 piece |
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 |
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|
ITEM |
STANDARD |
RESULT |
CONCLUSION |
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|
Appearance |
White crystalline powder |
White crystalline powder |
Conformity |
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|
Identification A: Infrared absorption spectrophotometry |
Conformity |
Conformity |
Conformity |
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Identification B: Melting point |
165°C~170°C |
165.9°C~167.9°C |
Conformity |
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Identification C: TLC |
Conformity |
Conformity |
Conformity |
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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 |
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|
Lead |
≤0.5 ppm |
<0.5 ppm |
Conformity |
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|
Nickel |
≤1 ppm |
<1 ppm |
Conformity |
|
|
Loss on drying |
≤0.5% |
0.2% |
Conformity |
|
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Microbial contamination: TAMC TYMC Escherichia coli Salmonella |
≤100 CFU/g ≤100 CFU/g Negative Negative |
<10 CFU/g <10 CFU/g Negative Negative |
Conformity |
|
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Bacterial endotoxins |
<2.0EU/g |
<2.0 EU/g |
Conformity |
|
|
Assay |
98.0% ~ 102.0% |
99.6% |
Conformity |
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|
Remark |
Samples |
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Conclusion |
Conformity |
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