Swapnroop Drugs & Pharmaceuticals offers Atomoxetine Hydrochloride API for pharmaceutical and formulation applications, subject to applicable quality and regulatory requirements.
Atomoxetine Hydrochloride is the hydrochloride salt of atomoxetine, a selective norepinephrine reuptake inhibitor. Atomoxetine is used therapeutically in the management of attention-deficit/hyperactivity disorder (ADHD).
Atomoxetine Hydrochloride is described as a white to off-white crystalline powder and is sparingly soluble in water.
Atomoxetine Hydrochloride is used as an active pharmaceutical ingredient in formulations intended for the treatment of ADHD. Commercial dosage forms include oral capsules, with strengths such as 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg of atomoxetine equivalent, depending on the product.
Atomoxetine Hydrochloride is described in the USP-NF monograph. USP specifies an assay range of 98.0%–102.0%, calculated on the dried basis. Identification includes infrared spectroscopy, chromatographic retention-time comparison and chloride identification.
Store in well-closed containers at room temperature, protected from unsuitable environmental conditions and handled according to the manufacturer's approved storage and handling requirements. USP specifies well-closed containers and room-temperature storage.
Swapnroop Drugs & Pharmaceuticals can supply Atomoxetine Hydrochloride API subject to availability, applicable specifications, documentation and regulatory requirements.
Contact Swapnroop Drugs & Pharmaceuticals for product specifications, COA, technical documentation and commercial requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR identification complies; chromatographic retention time corresponds to Atomoxetine R-isomer; chloride identification complies |
| Assay (HPLC) | 98.0% – 102.0% on dried basis |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | As per applicable approved specification |
| Individual Impurity | NMT 0.10% for unspecified individual impurity |
| Total Impurities | NMT 0.5% |
| Melting Point | As per approved specification |
| Solubility | Sparingly soluble in water |