Description

Mirtazapine n-Oxide-D3 CAS NO 1219155-54-0 is a deuterium-labeled analog of a key metabolite of the antidepressant drug Mirtazapine. This compound is essential for conducting precise and reliable pharmacokinetic and metabolic studies, ensuring accurate quantification and traceability in analytical workflows. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in drug development and bioanalytical method validation.

Application

• As an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the quantitative analysis of Mirtazapine and its metabolites in biological matrices.
• For use in drug metabolism and pharmacokinetics (DMPK) studies to elucidate metabolic pathways and clearance mechanisms.
• Critical in bioanalytical method development and validation to ensure accuracy, precision, and regulatory compliance (e.g., FDA, EMA guidelines).
• In clinical research for therapeutic drug monitoring (TDM) and patient stratification studies.
• Supporting forensic and toxicology investigations requiring definitive identification and quantification of substances.
• Utilized in reference standard preparation for quality control in pharmaceutical manufacturing.

Basic Information

Product Name	Mirtazapine n-Oxide-D3
CAS No.	1219155-54-0
Molecular Formula	C₁₇H₁₆D₃N₃O
Molecular Weight	Approx. 282.36 g/mol
Synonyms	1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine N-Oxide-d3; Mirtazapine N-Oxide Deuterated; Mirtazapine-d3 N-Oxide; Deuterated Mirtazapine Metabolite; Mirtazapine N-Oxide (D3); 6-Azamianserin N-Oxide-d3; Org 3770 Metabolite-d3
EINECS	Contact for details

Quality Control

Our deuterated reference standards are manufactured under strict quality control protocols to ensure the highest chemical purity and isotopic enrichment. Each batch is characterized using advanced analytical techniques including NMR, HPLC, and Mass Spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, isotopic purity (D-content), and analytical results, supporting compliance with GMP/GLP principles for research use.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant use and inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-content)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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