Clomipramine Hydrochloride is the hydrochloride salt of clomipramine and belongs to the tricyclic antidepressant class. It is a pharmaceutical active ingredient used in formulations for depression and obsessive-compulsive disorder (OCD), subject to appropriate medical and regulatory requirements.
Clomipramine Hydrochloride is identified by CAS No. 17321-77-6 and has the molecular formula C19H24Cl2N2 with a molecular weight of 351.32 g/mol. The parent clomipramine compound has CAS No. 303-49-1.
It is described as a white to almost white crystalline powder. USP and other pharmaceutical specifications include identification, assay, organic impurities, pH, loss on drying and residue on ignition testing.
Clomipramine Hydrochloride is primarily used as an active pharmaceutical ingredient in formulations associated with obsessive-compulsive disorder and depression. It is a tricyclic antidepressant with effects on serotonin and norepinephrine reuptake.
Clomipramine Hydrochloride can be evaluated through IR identification, HPLC assay, organic impurity testing, pH, loss on drying and residue on ignition. The USP monograph specifies an assay of 98.0%–102.0% on the dried basis.
Preserve in well-closed containers and protect from excessive moisture. Follow the approved manufacturer specification and applicable safety documentation. USP specifies well-closed containers for storage.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to USP identification tests |
| Assay (HPLC) | 98.0% – 102.0% on dried basis |
| Loss on Drying | NMT 0.1% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 0.5% |
| Melting Point | 191°C – 195°C |