Description

Desmethyl Mirtazapine-D4 Hydrochloride is a high-purity, stable isotope-labeled internal standard essential for precise quantitative analysis in pharmaceutical research and development. This deuterated compound is critical for ensuring the accuracy and reliability of bioanalytical methods, particularly in pharmacokinetic and metabolism studies. It is primarily utilized by analytical laboratories, contract research organizations (CROs), and pharmaceutical companies engaged in the development and quality control of mirtazapine and related therapeutics.

Application

• Bioanalytical Method Development and Validation: Serves as a critical internal standard for the quantification of mirtazapine and its metabolites in biological matrices (e.g., plasma, serum, urine) using LC-MS/MS and GC-MS.
• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Drug Metabolism Studies: Used to investigate metabolic pathways and identify potential drug-drug interactions for mirtazapine.
• Forensic and Clinical Toxicology: Supports the accurate identification and quantification of mirtazapine in forensic analysis and therapeutic drug monitoring (TDM).
• Pharmaceutical Quality Control (QC): Acts as a reference standard in impurity profiling and assay development for active pharmaceutical ingredient (API) manufacturers.
• Regulatory Submission Support: Provides essential data traceability and method robustness required for FDA, EMA, and other global regulatory agency filings.

Basic Information

Product Name	Desmethyl Mirtazapine-D4 Hydrochloride
CAS No.	1188266-12-7
Molecular Formula	C₁₇H₁₄D₄N₃·HCl
Molecular Weight	Approx. 313.8 g/mol
Synonyms	1,2,3,4,10,14b-Hexahydro-2-methyl-d4-pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine Hydrochloride; 6-Azamianserin-D4 Hydrochloride; Mirtazapine Metabolite D4 Hydrochloride; N-Desmethyl Mirtazapine-D4 HCl; 1,2,3,4,10,14b-Hexahydro-2-(methyl-d4)-pyrazino[2,1-a]pyrido[2,3-c][2]benzazepine Monohydrochloride
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards for stable isotope-labeled compounds. Each batch is characterized using advanced analytical techniques to confirm identity, isotopic purity, and chemical purity. Certificates of Analysis (COA) are provided, detailing results for assay, isotopic enrichment, and related substances. We support compliance with cGMP and ICH guidelines for pharmaceutical 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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.5%

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