Description

Imipramine Hydrochloride, USP

Imipramine Hydrochloride USP is a high-purity, pharmaceutical-grade tricyclic antidepressant (TCA) used in oral solid dosage forms for the treatment of major depressive disorder (MDD), nocturnal enuresis in children, and certain anxiety-related conditions. As a well-characterized first-generation TCA, it exhibits serotonin and norepinephrine reuptake inhibition with additional anticholinergic properties. Imipramine Hydrochloride

• Is a USP-compliant active pharmaceutical ingredient (API)
• Inhibits norepinephrine and serotonin reuptake in the central nervous system
• Is used in oral tablets and capsules for depression, panic disorder, and enuresis
• Possesses mild sedative, anticholinergic, and anxiolytic effects
• Is manufactured under Good Manufacturing Practice (GMP) conditions
• Is supplied with complete regulatory documentation including Certificate of Analysis (CoA), Drug Master File (DMF), and technical support

Imipramine Hydrochloride is chemically classified as a Dibenzazepine derivative and appears as a white to off-white crystalline powder. Its therapeutic effects are attributed to the modulation of monoaminergic neurotransmission and secondary binding to histaminergic and muscarinic receptors.

In pharmaceutical formulations, Imipramine Hydrochloride USP is used in:

• Treatment of major depressive disorder (MDD) in adults and adolescents
• Management of childhood nocturnal enuresis (bedwetting), typically as a second-line treatment
• Adjunctive treatment of panic disorder and certain phobias
• Off-label use in chronic pain, migraines, and cataplexy, under physician supervision

Formulations typically include immediate- or sustained-release oral tablets. Due to its narrow therapeutic index and potential cardiac side effects, precise control of dose and excipient compatibility is required in formulation.

CarboMer supplies Imipramine Hydrochloride USP with validated assay, enantiomeric purity, particle size distribution, and microbial control. Each batch complies with USP monograph requirements and is suitable for regulated pharmaceutical development and commercial production.

The material is packaged in sealed, light- and moisture-resistant, tamper-evident containers. Available in clinical, pilot, and full commercial volumes. Minimum order quantities (MOQ), lead times, and documentation—including CoA, SDS, and regulatory dossiers—are available upon request.

Each batch is tested for identity (IR, HPLC), assay, loss on drying, residue on ignition, related substances, and heavy metals. Certificates of Analysis (CoA), Safety Data Sheets (SDS), and full traceability documentation accompany every shipment.

As with all CarboMer CNS-active APIs, Imipramine Hydrochloride USP is supported by regulatory expertise, formulation assistance, and secure global sourcing to help bring clinically effective mental health therapies to market.