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Mannitol Injection Grade
Feb 08, 2017


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

&#8804;0.5 ppm

<0.5 ppm

Conformity

Nickel

&#8804;1 ppm

<1 ppm

Conformity

Loss  on  drying

&#8804;0.5%

0.2%

Conformity

Microbial contamination:
TAMC
TYMC
Escherichia coli
Salmonella

 
 
&#8804;100 CFU/g
&#8804;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