Item | Specifications | Results |
Appearance | White or almost white, crystalline powder or fine, colorless needles. | Complies |
Solubility | Slightly soluble in water, sparingly soluble in boiling water and in ethanol(96 per cent) | Complies |
Identification | ||
|
The principal spot in the chromatogram obtained with the test solution in similar in position, color and size to the principal spot in the chromatogram obtained with the reference solution | Complies |
A green color develops | Complies | |
|
When examined in ultraviolet light at 366 nm, an intense blue fluorescence appears which disappears almost completely on the addition of 1ml of HCL | Complies |
|
The solution gives reaction of sulphates | Complies |
Tests | ||
|
Solution S is clear and not more intensely colored than reference solution GY 6 | Complies |
|
5.7-6.6 | 6. 2 |
|
-237°~ -245° | -240. 5 ° |
|
Impurity C:≤10.0%
Any impurity eluted before quinine: ≤5.0% Any other impurity: ≤2.5% |
6.
3
%
2. 4 % N.A |
|
3.0%-5.0% | 4. 4 0% |
|
≤0.1% | 0. 071 % |
Assay | 99.0%-101.0% on dried substance | 99. 28 % |
Conclusion | The product conforms to BP2013 |