Mannitol

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