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TEST |
SPECIFICATIONS |
RESULTS |
Description |
White or almost white crystalline powder |
White crystalline powder |
Solubility |
Free soluble in Chloroform and in alcohol,very slightly soluble in water |
Complies |
Assay |
98.0% ~ 102.0% |
99.16% |
Identification (IR) |
Complies with the standard |
Complies |
Loss on drying |
≤0.5% |
0.15% |
Residue on ignition |
≤0.1% |
0.06% |
Heavy metals (Method II) |
≤10 ppm |
Complies |
|
Impurity A: ≤0.3% |
0.10% not detected 0.10% complies 0.26% |
Related substances (HPLC) |
Impurity B: ≤0.3% Impurity C: ≤0.3% Other single impurity: ≤0.1% |
|
|
Total impurities: ≤0.6% |
|
Specific rotation |
+12.0°~ +14.0° |
+13.15° |
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