| ≥1 piece |
Specification:USP 37/FCC8
|
Test items |
Acceptance criteria |
|
Appearance |
White to off-white powder |
|
Identification |
Conforms to standard |
|
Specific Rotation |
-40.0°~-43.4° |
|
Solubility |
Sparingly soluble in water and very soluble in alcohol and ethyl acetate |
|
Water |
≤5.0% |
|
pH |
5.0 ~7.0 |
|
Residue on ignition |
≤0.2% |
|
Lead |
≤1mg/kg |
|
Arsenic |
≤3mg/kg |
|
Related Substances |
Related Substance A: ≤1.5 % Any other impurity: ≤2.0% |
|
Residual solvents |
Methanol ≤ 0.1% Ethanol ≤ 0.1% |
|
Melting Point |
80 ~ 84 ℃
|
|
Assay |
97.0% —102.0% |