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  • Mannitol

Mannitol

CERTIFICATE  OF  ANALYSIS

Commodity

Mannitol

Batch  NO

1309196

Packing

25kg / bag

MFG. date

Sep.19.2013

Quantity

 5550kg

Expiry date

Sep.18.2015

Basis

Correspond  to    USP30

ITEM

STANDARD

RESULT

CONCLUSION

Appearance

White   crystalline  powder

White crystalline  powder

 

Conformity

Assay

96.0% ~ 101.5%

99.6%

Conformity

Identification

Infrared    absorption spectrophotometry

Conformity

 

 Conformity

 

Conformity

Melting  point

164℃169℃

165.7℃167.4℃

Conformity

Specific optical rotation

+137°~ +145°

 

  +139.8°

 

Conformity

Acidity

 (0.02mol/L NaOH)

Conformity

Conformity

Conformity

Loss    on  drying

≤0.3%

0.2%

Conformity

Chloride

≤0.007%

0.007%

Conformity

Sulphate

≤0.01%

0.01%

Conformity

Arsenic

≤1ppm

1ppm

Conformity

Reducing  sugars

Conformity

Conformity

Conformity

Residual solvents

The raw materials,   manufacturing process and product do not contain any of the solvents listed   in Residual SolventsUSP467>)

Remark


Conclusion

Conformity


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