Description

Mirtazapine CAS NO 61337-67-5 is a potent tetracyclic piperazinoazepine derivative, recognized as a noradrenergic and specific serotonergic antidepressant (NaSSA). This compound is of critical importance in the pharmaceutical industry for its unique mechanism of action, which effectively modulates neurotransmitter systems to treat major depressive disorders. It is an essential active pharmaceutical ingredient (API) required by pharmaceutical manufacturers, research institutions, and contract development and manufacturing organizations (CDMOs) for the formulation of finished dosage forms.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the manufacture of antidepressant medications.
• Formulation into various solid oral dosage forms, including tablets and orally disintegrating tablets (ODTs).
• Use in clinical research and development for studying novel neuropsychiatric treatments.
• Reference standard in analytical laboratories for quality control and method validation.
• Intermediate in the synthesis of related pharmaceutical compounds and metabolites for research.
• Supply to contract manufacturers for the production of generic pharmaceutical products.

Basic Information

Product Name	Mirtazapine
CAS No.	61337-67-5
Molecular Formula	C₁₇H₁₉N₃
Molecular Weight	265.35 g/mol
Synonyms	1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine; 6-Azamianserin; Mirtazapinum; Mirtazapin; Remeron; Zispin; Norset; Avanza; Mirtabene; Mirtazon
EINECS	Contact for details

Quality Control

Our Mirtazapine is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and strength, aligning with ICH guidelines and current Good Manufacturing Practices (cGMP). A detailed Certificate of Analysis (COA) documenting results for assay, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.10% Total impurities: NMT 0.50%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	NMT 20 ppm
Loss on Drying	NMT 0.5%
Sulfated Ash	NMT 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.