Dosulepin, also known as Dothiepin, is a tricyclic antidepressant belonging to the class of monoamine reuptake inhibitors. It increases the availability of neurotransmitters at synaptic sites by inhibiting the reuptake of biogenic amines. Dosulepin also exhibits anticholinergic, antihistaminic and sedative properties.
Dosulepin has the molecular formula C₁₉H₂₁NS, molecular weight 295.4 g/mol, and CAS Number 113-53-1. Its commonly used pharmaceutical salt is Dosulepin Hydrochloride, with CAS 897-15-4, molecular formula C₁₉H₂₂ClNS, and molecular weight 331.90 g/mol.
Dosulepin is a tricyclic antidepressant (TCA) with antidepressant and anxiolytic properties. It has historically been used in the treatment of depressive disorders and associated anxiety symptoms.
Dosulepin primarily inhibits the reuptake of norepinephrine and serotonin, increasing their concentration in the synaptic cleft. Its additional anticholinergic, antihistaminic and sedative activities contribute to its overall pharmacological profile.
Dosulepin is associated with pharmaceutical treatment of:
Its use is restricted in some markets because of its narrow therapeutic index and toxicity in overdose.
Dosulepin Hydrochloride is the commonly used pharmaceutical salt form. The British Pharmacopoeia recognizes Dosulepin Hydrochloride as a pharmaceutical substance, and UK regulatory documentation describes it as a white or faintly yellow crystalline powder that is freely soluble in water, ethanol and methylene chloride.
Important quality-control parameters for Dosulepin Hydrochloride include:
The exact limits should correspond to the applicable BP/Ph. Eur. monograph or approved API specification.
Dosulepin Hydrochloride intended for pharmaceutical manufacturing should comply with applicable GMP, pharmacopoeial and regulatory requirements.
The British Pharmacopoeia maintains a reference standard for Dosulepin Hydrochloride with CAS 897-15-4 and declared content of 100.0% of C₁₉H₂₁NS·HCl.
Dosulepin Hydrochloride should be stored in appropriately closed containers under controlled pharmaceutical storage conditions. Reference-standard material is stored under refrigerated conditions of 2–8°C.
Dosulepin Hydrochloride is relevant to pharmaceutical manufacturers involved in the development and manufacture of tricyclic antidepressant formulations.
For commercial procurement, customers should verify the salt form, assay, purity, related substances, pharmacopoeial compliance and batch-specific CoA.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 150°C – 154°C |