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 |
negative 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% |
99.5% |
|
Conclusion |
The test results above BP2009 |
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 |
negative 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% |
99.5% |
|
Conclusion |
The test results above BP2009 |
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