Mannitol
Mannitol

Item specifics

color
white crystalline powder
Purity
99%min

Review

Description

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