| No. |
TEST |
SPECIFICATION |
OBSERVATION |
| 1. |
Description
|
A white or almost white, crystalline fine powder, colourless needles |
Almost white crystalline Powder |
| 2 |
Solubility |
Slightly soluble in water, sparingly soluble in boiling water and in alcohol.
|
Slightly soluble in water, sparingly soluble in boiling water and in alcohol. |
| 3 |
Identification |
A) BY TLC:
The principal spot in the chrometogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution. |
Complies |
| |
|
B)A green colour develops when treated with bromine water and ammonia |
Complies |
| |
|
C) An intense blue fluorescence appears at 366nm when treated with dilute sulphuric acid which disappear completely by adding lml of HCL. |
Complies |
| |
|
D) The solution in dilute HCL gives reaction of Sulphate. |
Complies |
| |
|
E) The pH of 1.0% solution in water is 5.7 to 6.6.
|
6.2 |
| 4 |
Appearance of Soln. |
Solution S is clear and not more intensely coloured than reference solution GY6.
|
Complies |
| 5 |
pH
|
pH is 5.7 to 6.6 (1 % suspension in water) |
6.2 |
| 6 |
Specific Optical Rotation |
-237" to -245'(0.500 g in 25mI of 0.1 M HCL) |
-240 |
| 7 |
Other Cinchona
Alkaloids
(By HPLC)
|
Dihydroquinine : NMT 10.0% Imp.Bedore Quinine : NMT 5.0% Any Other Impurity : NMT 2.5% |
5.30%
1%
0.10% |
| 8 |
Loss on Drying
|
3.0% to 5.0% w/w (Determined with 1.000g@ 105ºC) |
4.8%w/w |
| 9 |
Sulphated Ash |
NMT 0.1% w/w (Determined on 1.0g) |
0.04% |
| 10 |
Assay |
99.0% to 101.0% on dried basis |
99.30% |
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