Description

8-Hydroxy Mirtazapine is a key pharmaceutical intermediate and metabolite of the antidepressant mirtazapine. This compound matters for its critical role in drug metabolism studies, analytical reference standard preparation, and the research and development of new therapeutic agents. It is primarily needed by pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers of active pharmaceutical ingredients (APIs) and high-purity reference materials.

Application

• Primary use as a reference standard in analytical chemistry for the quantification and qualification of mirtazapine and its metabolites.
• Critical pharmaceutical intermediate in the synthesis and research of neuroactive compounds.
• Essential material for drug metabolism and pharmacokinetic (DMPK) studies to understand the biotransformation of mirtazapine.
• Used in the development and validation of analytical methods such as HPLC, LC-MS, and GC-MS in bioanalytical laboratories.
• Research chemical for neuroscience and pharmacology studies investigating the structure-activity relationships of tetracyclic antidepressants.
• Starting material or impurity standard in the quality control of mirtazapine API manufacturing processes.

Basic Information

Product Name	8-Hydroxy Mirtazapine
CAS No.	102335-57-9
Molecular Formula	C₁₇H₁₉N₃O
Molecular Weight	281.35 g/mol
Synonyms	8-Hydroxymirtazapine; 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-8-ol; Mirtazapine Metabolite 8-OH; Mirtazapine 8-Hydroxy Derivative; 2-Methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-8-ol; N-Methyl-8-hydroxy-mianserin; 8-OH-Mirtazapine
EINECS	Contact for details

Quality Control

Our 8-Hydroxy Mirtazapine is produced under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical research and development. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profiles is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled and stored accordingly to maintain stability.

Specification

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

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