Commodity

Mannitol

Batch? NO

20110411

MFG.date

Apr.11.2011

Expiry date

Apr.10.2013

Basis

Correspond? to? BP2007

ITEM

STANDARD

RESULT

Appearance

White crystalline powder

White crystalline powder

Identification A:
Infrared absorption spectrophotometry

Conformity

Conformity

Identification B:
Melting? point

165^οC-170^οC

166.1^οC-167.8^οC

Identification C:TLC

Conformity

Conformity

Identification?D:
Specific? optical? rotation

+23°-+25°

+23.9°

Appearance of solution

Clear and colourless

Clear and colourless

Conductivity

≤20us/cm

3.7us/cm

Reducing? sugars

≥12.8 ml

18.0ml

Related ?substances:
The area of any peak
Total ?impurities

≤2%
≤2%

<2%
<2%

Lead

≤0.5 ppm

<0.5 ppm

Nickel

≤1 ppm

<1 ppm

Loss? on? drying

≤0.5%

0.2%

Microbial contamination:
TAMC
TYMC
Escherichia coli
Salmonella

≤100 CFU/g
≤100 CFU/g
Negative
Negative

10 CFU/g
<10 CFU/g
Negative
Negative

Bacterial? endotoxins

<2.5 IU/g

<1.25IU/g

Assay

98.0%-102.0%

99.7%

Conclusion

Conformity