Doxepin Hydrochloride is a pharmaceutical active ingredient belonging to the tricyclic antidepressant class. It is the hydrochloride salt of doxepin and is used in pharmaceutical formulations for its antidepressant and anxiolytic properties. Doxepin also has antihistaminic activity and is used in certain formulations for insomnia and related indications.
Doxepin Hydrochloride is the hydrochloride salt of doxepin, a dibenzoxepin derivative. It acts primarily by inhibiting the reuptake of norepinephrine and serotonin in the central nervous system. It also has significant histamine H1-receptor antagonist activity.
Doxepin is a synthetic pharmaceutical compound available as the hydrochloride salt for pharmaceutical applications. Doxepin Hydrochloride is supplied as an active pharmaceutical ingredient for use by pharmaceutical manufacturers and formulation developers.
Doxepin produces its antidepressant effects primarily through inhibition of norepinephrine and serotonin reuptake. Its strong H1-antihistamine activity contributes to sedative effects and is particularly relevant to its use in certain insomnia formulations.
Doxepin Hydrochloride is used in pharmaceutical formulations associated with:
Doxepin Hydrochloride is generally described as a white to slightly yellowish crystalline powder. It is soluble in water and alcohol and can be formulated into different pharmaceutical dosage forms.
Doxepin Hydrochloride API intended for pharmaceutical manufacturing should be tested using validated analytical procedures for identity, assay, related substances, residual solvents, water content and other applicable quality attributes. Batch-specific specifications should be followed for commercial release.
Doxepin Hydrochloride is a pharmaceutical active ingredient used in antidepressant and other pharmaceutical formulations. Pharmaceutical manufacturers and formulation developers can evaluate the API based on applicable pharmacopoeial standards, analytical documentation, regulatory requirements and batch-specific Certificate of Analysis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.0 – 6.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | Approximately 185°C – 191°C |