Atomoxetine Hydrochloride (Atomoxetine HCl) is a pharmaceutical active ingredient belonging to the selective norepinephrine reuptake inhibitor class. It is the hydrochloride salt of the R(-) isomer of atomoxetine and is used in pharmaceutical formulations for the treatment of attention-deficit/hyperactivity disorder (ADHD).
Atomoxetine Hydrochloride is identified by CAS No. 82248-59-7, molecular formula C₁₇H₂₁NO·HCl, and molecular weight 291.82 g/mol. It is described as a white to practically white solid/crystalline powder and has a reported water solubility of approximately 27.8 mg/mL.
Atomoxetine Hydrochloride is used as an active pharmaceutical ingredient in medicines for ADHD. Commercial atomoxetine capsules are available in strengths equivalent to 10, 18, 25, 40, 60, 80 and 100 mg of atomoxetine, depending on the product.
Atomoxetine Hydrochloride is described in the USP-NF monograph. The USP definition specifies NLT 98.0% and NMT 102.0% of atomoxetine hydrochloride, calculated on the dried basis. Identification includes infrared spectroscopy, chromatographic retention-time comparison and chloride identification.
Atomoxetine Hydrochloride can be supplied subject to product availability, approved specifications and applicable regulatory requirements. Relevant technical documentation may include:
Contact Swapnroop Drugs & Pharmaceuticals for Atomoxetine Hydrochloride API requirements, specifications, documentation and commercial enquiries.
| Parameter | Specification |
|---|---|
| Appearance | White to practically white crystalline powder/solid |
| 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 elemental impurity requirements |
| Individual Impurity | NMT 0.10% for unspecified individual impurity |
| Total Impurities | NMT 0.5% |
| Solubility | Soluble in water; approximately 27.8 mg/mL reported |