|
Test Items
|
Specification
|
Test Results
|
|
Appearance
|
white oralmost white,crystalline powder
|
Conform
|
|
Solubility
|
Freely soluble in water,practically insoluble or very slightly soluble in alcohol and in methylene chloride.
|
Conform
|
|
Identification
|
A
|
The UV absorption spectrum of the sample shows an absorption maximum at 276nm.The specific absorbance at the Maximum is55 to 64.
|
Conform
|
|
B
|
Infraed absorption spectrophotometry.
|
Conform
|
|
C
|
Chromatogram obtained with test solution (b) is similar in position color & size to the principal spot in the chromatogram obtained with the reference solution.
|
Conform
|
|
D
|
An orange-red color develop in methylene chloride layer.
|
Conform
|
|
E
|
It geves reaction (a) of sulphates.
|
Conform
|
|
Appearance of solution
|
Solution S is clear and not more intensely coloured than reference solution in BY6.
|
Conform
|
|
Optical rotation
|
﹣0.10° to +0.10°determined on solution S.
|
+0.01°
|
|
Acidity or alkalinity
|
NMT 0.4ml of 0.01M HCL is required to change the color of the indicator to red.
|
Conform
|
|
Related substances
|
Impurity J ≤0.20%
|
Conform
|
|
Any other impurity ≤0.30%
|
Conform
|
|
Total impurity ≤1.0%
|
Conform
|
|
Boron
|
≤50ppm
|
Conform
|
|
Sulphated ash
|
≤0.10%
|
0.06%
|
|
Loss on drying
|
≤0.5%
|
0.30%
|
|
Assay(on dried basis)
|
98.0~101.0%
|
98.8%
|
|
Conclusion
|
The test results above BP2009
|
