Buspirone Hydrochloride is the hydrochloride salt of buspirone, an azaspirodecanedione compound used as an anxiolytic pharmaceutical ingredient. It is chemically described as N-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. FDA identifies buspirone hydrochloride as a white crystalline, water-soluble compound with a molecular weight of approximately 422.0 and molecular formula C₂₁H₃₁N₅O₂·HCl.
Buspirone Hydrochloride is a pharmaceutical active ingredient belonging to the azaspirodecanedione class. It is used in the manufacture of oral pharmaceutical formulations containing buspirone hydrochloride.
FDA's substance database confirms the molecular formula and molecular weight, while the FDA-approved labeling describes the material as a white crystalline, water-soluble compound.
Buspirone Hydrochloride is used as an active pharmaceutical ingredient in oral dosage forms. It is the active ingredient in buspirone hydrochloride tablets available in strengths including 5 mg, 10 mg, 15 mg and 30 mg.
Buspirone Hydrochloride has a USP monograph with defined requirements for assay, identification and water content. Publicly available USP material specifies an assay range of 97.5%–102.5% on the as-is basis and water content of NMT 0.5%.
| Parameter | Specification |
|---|---|
| Identification | Complies — IR identification; retention time corresponds to Buspirone Hydrochloride RS |
| Assay (HPLC) | 97.5% – 102.5% |
| Loss on Drying | NMT 0.5% |
| Individual Impurity | NMT 0.1% |
| Water Content | NMT 0.5% |
| Solubility | Very soluble in water; freely soluble in methanol and methylene chloride |