Description

Mirtazapine n-Oxide is a significant pharmaceutical intermediate and metabolite of the antidepressant drug Mirtazapine. This compound is crucial for research and development in the pharmaceutical industry, particularly for metabolic studies, impurity profiling, and the synthesis of reference standards. It is primarily utilized by pharmaceutical R&D laboratories, analytical service providers, and manufacturers of active pharmaceutical ingredients (APIs) who require high-purity chemical references to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Mirtazapine and its related substances in drug products and raw materials.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and pharmacodynamic research to understand the metabolic pathways of Mirtazapine.
• Impurity Profiling: Serves as a key impurity marker in the quality control and stability testing of Mirtazapine API, helping to ensure compliance with ICH guidelines.
• Organic Synthesis Intermediate: Employed in chemical synthesis for the development of novel derivatives or for process chemistry research related to tetracyclic antidepressants.
• Analytical Method Development: Used to develop, validate, and calibrate analytical methods such as HPLC, LC-MS, and GC-MS in regulatory and quality control laboratories.

Basic Information

Product Name	Mirtazapine n-Oxide
CAS No.	155172-12-6
Molecular Formula	C₁₇H₁₉N₃O
Molecular Weight	281.35 g/mol
Synonyms	1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 5-Oxide; Mirtazapine N-Oxide; Mirtazapine Impurity F (EP); Mirtazapine Related Compound F; Remeron N-Oxide; 6-Azapiasine 5-Oxide; Mirtazapine Metabolite N-Oxide
EINECS	Contact for details

Quality Control

Our Mirtazapine n-Oxide is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification, assay, and impurity profiling via HPLC and other spectroscopic methods, to ensure it meets high-purity standards suitable for pharmaceutical research. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment, supporting compliance with relevant pharmacopeial guidelines (e.g., EP, USP) for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions 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 impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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