Description

Mirtazapine CAS NO 85650-52-8 is a tetracyclic piperazinoazepine derivative, recognized as a potent noradrenergic and specific serotonergic antidepressant (NaSSA). This active pharmaceutical ingredient (API) is critical for the formulation of effective antidepressant medications. It is primarily required by pharmaceutical manufacturers, research institutions, and compounding facilities engaged in the development and production of neuropsychiatric therapeutics.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antidepressant tablets, orally disintegrating tablets (ODTs), and other solid dosage forms.
• Generic Drug Production: Serves as the key raw material for generic versions of branded mirtazapine medications, ensuring cost-effective treatment options.
• Clinical Research: Utilized in preclinical and clinical studies to investigate mechanisms of action, pharmacokinetics, and potential new therapeutic applications.
• Reference Standard: High-purity grades are used as analytical reference standards in quality control laboratories for method development and validation.
• Compounding Pharmacy: Employed by specialized compounding pharmacies to create customized dosage strengths or formulations for patients with specific needs.

Basic Information

Product Name	Mirtazapine
CAS No.	85650-52-8
Molecular Formula	C₁₇H₁₉N₃
Molecular Weight	265.35 g/mol
Synonyms	6-Azamianserin; 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine; Mirtazapinum; Mirtazapin; Remeron (Brand Name); Zispin (Brand Name); Norset (Brand Name); Avanza (Brand Name)
EINECS	Contact for details

Quality Control

Our Mirtazapine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. We provide full traceability and support regulatory submissions with detailed documentation. Certificates of Analysis (COA) are available upon request, detailing purity, identity, and impurity profiles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to minimize exposure to atmospheric moisture. Store away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.15% Total impurities: ≤ 0.5%
Heavy Metals	≤ 20 ppm

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