Items |
Standard |
Appearance |
Yellow, crystalline powder. |
Solubility |
Freely soluble in water, sparingly soluble in ethanol. |
Identification |
The retention time of the main peak is consistent with that of the main peak in the control map. |
Color reaction |
Chlorides reaction |
PH |
2.3~2.9 |
Sulfated ash |
≤0.2% |
Light-absorbing impurities(430nm) |
430nm:≤0.50 (anhydrous substance) |
Light-absorbing impurities(430nm) |
490nm:≤0.20 (anhydrous substance) |
Water |
≤2.0% |
Related substances |
Impurity A: NMT 0.5% |
Impurity B: NMT 1.0% |
Impurity C: NMT 2.0% |
Impurity D: NMT 2.0% |
Impurity E: NMT 2.0% |
Any other impurity: NMT 1.0% |
Sum of impurities D,E and F: NMT 1.0% |
Total impurities: NMT 3.5% |
Residual Methanol |
≤0.3% |
Assay |
94.5%~102.0% (anhydrous substance) |