Mirtazapine EP/USP

Description

Mirtazapine EP/USP is a high-purity tetracyclic antidepressant used in pharmaceutical formulations for the treatment of major depressive disorder and related mood conditions. Compliant with European Pharmacopoeia (EP) and United States Pharmacopeia (USP) standards, it is valued for its unique mechanism of action, rapid onset of antidepressant effect, and favorable tolerability profile.

Mirtazapine is chemically designated as 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine. It appears as a white to off-white crystalline powder that is practically insoluble in water and soluble in organic solvents, making it suitable for formulation into oral solid dosage forms.

In pharmaceutical and clinical applications, Mirtazapine EP/USP is used in:

• Oral tablets and orally disintegrating tablets for depression treatment
• Management of depressive disorders with associated anxiety or insomnia
• Adjunct therapy in treatment-resistant depression
• Research involving noradrenergic and serotonergic modulation
• Pharmacokinetic and bioavailability studies

Mirtazapine EP/USP functions through antagonism of central presynaptic alpha-2 adrenergic receptors, leading to increased release of norepinephrine and serotonin. It also selectively blocks certain serotonin receptors while enhancing serotonergic transmission, contributing to its antidepressant and anxiolytic effects.

CarboMer supplies Mirtazapine EP/USP with assay, purity, residual solvents, particle size, and microbial quality. The material meets EP and USP monograph specifications and is suitable for regulated pharmaceutical manufacturing.

The material is packaged in sealed, moisture-resistant, tamper-evident containers and protected from excessive light. Available in laboratory, pilot, and commercial-scale quantities. Documentation includes Certificate of Analysis (CoA), Safety Data Sheet (SDS), and complete traceability.

Each batch is tested for identity (IR, HPLC), assay on anhydrous basis, impurity profile, water content, and microbial limits. Technical support is available to assist with formulation development and regulatory compliance.

As with all CarboMer supplied central nervous system active ingredients, Mirtazapine EP/USP is supported by dependable global supply, stringent quality control, and expert technical guidance to ensure safe, effective, and consistent pharmaceutical product development.