Duloxetine Hydrochloride (Duloxetine HCl) is a pharmaceutical active pharmaceutical ingredient (API) belonging to the serotonin-norepinephrine reuptake inhibitor (SNRI) class. It is used in pharmaceutical formulations for the management of major depressive disorder, generalized anxiety disorder and certain chronic pain conditions.
Duloxetine HCl is the hydrochloride salt form of duloxetine. It is a synthetic small-molecule compound that increases the availability of serotonin and norepinephrine in the central nervous system by inhibiting their reuptake.
Duloxetine Hydrochloride is a pharmaceutical-grade API commonly used in the manufacture of oral pharmaceutical formulations, particularly delayed-release dosage forms.
Duloxetine HCl inhibits the neuronal reuptake of serotonin (5-HT) and norepinephrine (NE). Increased concentrations of these neurotransmitters contribute to its antidepressant, anxiolytic and pain-modulating effects.
Duloxetine HCl API is used in pharmaceutical formulations for:
The approved indications depend on the specific formulation and applicable regulatory labeling.
Duloxetine HCl is generally described as a white to slightly brownish-white solid. It is a hydrochloride salt of duloxetine and is used as a pharmaceutical ingredient in oral dosage formulations.
Duloxetine HCl API intended for pharmaceutical manufacturing should be produced under appropriate GMP controls and tested according to applicable regulatory requirements. Quality evaluation may include identification, assay, related substances, water content, residual solvents, elemental impurities and other relevant quality attributes.
Duloxetine HCl is an established pharmaceutical API used in CNS and pain-management formulations. Pharmaceutical manufacturers and formulation developers can evaluate the material based on applicable regulatory requirements, analytical documentation, quality specifications 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 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 168°C – 172°C |