Items

Specification

Appearance

White or almost white or colorless, fine,silky needles, often in clusters

Solubility

Soluble in water, freely soluble in ethanol (96%)

Identification

A)  TLC

The principal spot in the chromatogram obtained with the test solution is similar in position,color and size to the principal spot in the chromatogram obtained with the reference solution

B)Bromine and ammonia

A green color develops when treated with bromine water and dilute ammonia

C) Fluorescence

When examined in ultraviolet light at 366nm, an intense blue fluorescence appears which disappears almost completely on addition of 1ml of HCL

D) Characteristic of chlorides

It gives the reactions of chlorides

E) Test for pH

Should comply

Tests

1) Appearance of solution

Solution S is clear and not more intensely colored than references solution GY₆

2)PH

6.0~6.8

3)Specific optical rotation

-245° to  -258°

4) Other cinchona alkaloids impurity C

Any impurity eluted before quinidine

Any other impurity

≤10%

≤5% sulphates

≤2.5%

5) Loss on drying

6%~10%

6) Sulphates

≤500ppm

7) Boron

Should comply

8)Sulphates ash

≤0.1%

Assay (on dried basis)

99.0%~101.0%