Duloxetine is a pharmaceutical active pharmaceutical ingredient (API) belonging to the serotonin-norepinephrine reuptake inhibitor (SNRI) class. It is used in pharmaceutical formulations for the treatment of major depressive disorder, generalized anxiety disorder and certain chronic pain conditions.
Duloxetine is a synthetic small-molecule compound that increases the availability of serotonin and norepinephrine in the central nervous system by inhibiting their reuptake. It is commonly supplied as Duloxetine Hydrochloride for pharmaceutical formulation.
Duloxetine is a pharmaceutical API used in the manufacture of oral dosage forms, including delayed-release capsules. Its pharmacological activity results primarily from inhibition of serotonin and norepinephrine reuptake.
Duloxetine selectively inhibits the reuptake of serotonin (5-HT) and norepinephrine (NE) at neuronal synapses. This increases their concentrations in the central nervous system and contributes to its antidepressant, anxiolytic and analgesic effects.
Duloxetine API is used in pharmaceutical formulations for:
Specific indications depend on the approved formulation and applicable regulatory labeling.
Duloxetine is generally described as a white to slightly brownish-white solid. It is practically insoluble in water, while the hydrochloride salt has improved pharmaceutical handling characteristics.
Duloxetine API intended for pharmaceutical manufacturing should be produced under appropriate GMP controls and tested according to applicable quality and regulatory requirements. Quality evaluation may include identification, assay, related substances, residual solvents, water content, elemental impurities and other relevant quality attributes.
Duloxetine is an established pharmaceutical API used in CNS and pain-management formulations. Pharmaceutical manufacturers and formulation developers can evaluate Duloxetine 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 | Conforms to Duloxetine identification tests |
| 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 |