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Clomipramine hydrochloride
| ITEMS | LIMIT |
| Characteristics | White or slightly yellow crystalline powder, slightly hygroscopic; |
| Freely soluble in water and in methylene chloride, soluble in alcohol | |
| Identification | B. IR spectrum is in concordance with the reference one |
| E. yields reaction characteristics of chloride | |
| Appearance of solution | Solution S: clear & not more intensely colored than the reference solution Y5 |
| pH | 3.5 ~ 5.0 |
| Related substances | Impurity B: NMT 0.1% |
| Impurity C, D: each NMT 0.2% | |
| Impurity F: NMT 0.1% | |
| Any other impurity: NMT 0.1% | |
| Total of other impurities: NMT 0.2% | |
| Total of impurities: NMT 1.0% | |
| Heavy Metals | NMT 20ppm |
| Loss on drying | NMT 0.5% |
| Sulfated ash | NMT 0.1% |
| Assay (dried substances) | 99.0% ~ 101.0% |
As antidepressants
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