Description

Mirtazapine-D3 is a deuterium-labeled analog of the tetracyclic antidepressant mirtazapine, specifically designed for use as an internal standard in analytical chemistry. This high-purity stable isotope-labeled compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and bioequivalence studies. It is a critical tool for pharmaceutical research laboratories, contract research organizations (CROs), and quality control departments requiring precise measurement of mirtazapine in complex biological matrices.

Application

• Internal Standard for LC-MS/MS: Primary application as a quantitative internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods for mirtazapine.
• Pharmacokinetic Research: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical studies.
• Bioanalytical Method Development & Validation: Used to develop and validate robust, precise, and accurate analytical methods for mirtazapine in plasma, serum, and other biological fluids.
• Therapeutic Drug Monitoring (TDM): Supports assays designed to monitor mirtazapine concentrations in patient samples to optimize dosage and ensure therapeutic efficacy.
• Metabolite Studies: Aids in the identification and quantification of mirtazapine metabolites in research focused on metabolic pathways.
• Forensic & Toxicology Analysis: Provides a reliable reference for the precise quantification of mirtazapine in forensic and toxicological investigations.
• Pharmaceutical Quality Control: Can be utilized in impurity profiling and assay development for finished drug product testing.
• Reference Material for GLP/GMP Studies: Serves as a certified reference material in studies conducted under Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines.

Basic Information

Product Name	Mirtazapine-D3
CAS No.	1216678-68-0
Molecular Formula	C₁₇H₁₆D₃N₃
Molecular Weight	269.36 g/mol
Synonyms	1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine-2,3,4-tri-d3; 6-Azamianserin-D3; Mirtazapine (methyl-d3); Remeron-D3 (labeled); Deuterated Mirtazapine; Mirtazapine-d3 Internal Standard; (±)-Mirtazapine-d3
EINECS	Contact for details

Quality Control

Our Mirtazapine-D3 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch undergoes comprehensive testing, including assay by HPLC, determination of isotopic enrichment by MS, and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the chemical purity (typically ≥98%) and isotopic purity (typically ≥99 atom % D). Our quality commitment supports research requiring reliable and consistent reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity	≥ 99.0 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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