Items
|
Specifications
|
Results
|
Characters
|
White or almost white crystalline powder
|
White crystalline powder
|
Indentification
|
Complies
|
Complies
|
Acidity or alkalinity
|
PH 5.0-7.5
|
PH 6.6
|
Clarity of solution
|
No more opalescent than reference suspension I
|
Complies
|
Color of solution
|
Not more intensely coloured than intensity Y2 or G2 of the range of refernce
|
Complies
|
Loss on drying
|
Not more than 1.0%
|
0.1%
|
Potency
|
1440 u/mg~1680 u/mg
|
1592 u/mg
|
Related substances
|
Any other impurities not more than 1%
|
Complies
|
Transmittance(400nm)
|
Not less than 90%
|
96%
|
Assay (on dries basis)
|
Not less than 95.0%
|
99.7%
|