Description

Desmethyl Mirtazapine is a key pharmaceutical intermediate and metabolite of the antidepressant drug Mirtazapine. This compound is of significant importance in the research, development, and quality control of neuropsychiatric medications. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug metabolism studies, impurity profiling, and the synthesis of advanced therapeutic agents.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of Mirtazapine and related therapeutic compounds.
• Reference Standard: Used as a certified reference material (CRM) for analytical method development and validation in pharmacokinetic studies.
• Metabolite Studies: Essential for investigating the metabolic pathways, bioavailability, and clearance of Mirtazapine in biological systems.
• Impurity Profiling: Serves as a known impurity standard to ensure the purity and safety of final drug formulations according to ICH guidelines.
• Research Chemical: Employed in preclinical and clinical research to study the structure-activity relationships (SAR) of tetracyclic antidepressants.
• Quality Control (QC): Integral for HPLC, LC-MS, and other analytical techniques to assay drug substance and product quality.

Basic Information

Product Name	Desmethyl Mirtazapine
CAS No.	61337-68-6
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-Desmethyl Mirtazapine; Mirtazapine Metabolite; N-Desmethyl Mirtazapine; Org 3770 Metabolite; 2-Methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
EINECS	Contact for details

Quality Control

Our Desmethyl Mirtazapine is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the stringent requirements for pharmaceutical intermediates and reference standards. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles by validated methods (e.g., HPLC, NMR) is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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