CERTIFICATEOFANALYSIS Name:ClomipramineHydrochloride BatchNumber:20120101BatchSize:100kg ...
Items of Test | Limites of Test | Result of Test |
Appearance | A white or slightly yellow, crystalline powder.lightly hygroscopic | Meets |
Identification | A:Melting point:191-195℃ B:IR absorption spectrophotometry C.D.E should comply. | Meets |
Appearance of solution | Clear,not more intense than Y5 | meets |
Solubility | Freely soluble in water and in methlylene chloride,soluble in alcohol | Meets |
PH | 3.5-5.0 | 4.2 |
Sulphated ash | ≤0.1% | 0.08% |
Heavy Metals | ≤20ppm | Meets |
Loss on drying | ≤0.5% | 0.31% |
Related substances | Impurity B≤1.0% Impurity C.D≤0.2% Impurity F≤0.1% Any impurity ≤0.1% Total of other impurity≤0.2% Total impurities≤1.0% | Meets Meets Meets Meets Meets Meets |
Assay(ondried basis) | 99.0%-101.0%(USP) | 99.15% |
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