Description

Mirtazapine Hemihydrate CAS NO 341512-89-8 is the hemihydrate crystalline form of the active pharmaceutical ingredient Mirtazapine, a noradrenergic and specific serotonergic antidepressant (NaSSA). This high-purity intermediate is critical for ensuring the efficacy, stability, and batch-to-batch consistency of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and advanced research institutions for the development and production of antidepressant medications.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of antidepressant tablets, orally disintegrating tablets (ODTs), and other solid dosage forms.
• Reference Standard: Serves as a certified reference material (CRM) for quality control laboratories to validate analytical methods like HPLC and UV.
• Research & Development: Used in preclinical and clinical studies for investigating pharmacological profiles, metabolite synthesis, and new drug delivery systems.
• Generic Drug Manufacturing: A key starting material for producing bioequivalent generic versions of branded antidepressant drugs.
• Process Development: Employed in optimizing crystallization, purification, and scale-up processes in pilot plants.

Basic Information

Product Name	Mirtazapine Hemihydrate
CAS No.	341512-89-8
Molecular Formula	C17H19N3O · ½H2O
Molecular Weight	281.36 g/mol (anhydrous basis)
Synonyms	1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hemihydrate; 6-Azamianserin hemihydrate; Mirtazapine monohydrate (hemihydrate); Remeron (base compound); Org 3770 (hemihydrate); (RS)-2-Methyl-1,2,3,4,10,14b-hexahydro-2H-pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine hemihydrate
EINECS	Contact for details

Quality Control

Our Mirtazapine Hemihydrate is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and impurity profiles, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbial limits is provided with every shipment to ensure regulatory compliance and supply chain transparency.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water Content (KF)	2.5% - 4.0%
Related Substances (HPLC)	Individual impurity: NMT 0.10% Total impurities: NMT 0.50%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 10 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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