Description

Doxepin-D3 Hcl (n-Methyl-D3) is a deuterium-labeled analog of the tricyclic antidepressant doxepin, specifically labeled on the N-methyl group. This stable isotope-labeled compound is an essential internal standard for the accurate quantification of doxepin in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in bioanalytical method development, pharmacokinetic studies, and drug metabolism research to ensure data integrity and regulatory compliance.

Application

• Internal Standard for Bioanalysis: Serves as a critical internal standard in the quantitative LC-MS/MS analysis of doxepin in plasma, serum, and other biological samples.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables precise tracking of drug concentration over time in clinical and non-clinical studies.
• Drug Metabolism and Disposition Research: Used in ADME (Absorption, Distribution, Metabolism, Excretion) studies to understand the fate of the parent drug.
• Forensic and Clinical Toxicology: Supports accurate quantification in forensic analysis and therapeutic drug monitoring (TDM) programs.
• Method Development and Validation: Essential for developing, validating, and transferring robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Reference Material for Quality Control: Acts as a high-purity certified reference material (CRM) for calibrating instruments and verifying analytical procedures in QC laboratories.

Basic Information

Product Name	Doxepin-D3 Hcl (n-Methyl-D3)
CAS No.	347840-07-7
Molecular Formula	C19H18D3NO•HCl
Molecular Weight	316.86 g/mol
Synonyms	Doxepin-d3 hydrochloride; Doxepin (N-methyl-d3) hydrochloride; (E/Z)-Doxepin-d3 hydrochloride; 3-(Dibenz[b,e]oxepin-11(6H)-ylidene)-N-methyl-d3-propan-1-amine hydrochloride; N-Methyl-d3-doxepin hydrochloride; NSC 108168-d3; Sinequan-d3; Adapin-d3; Deptran-d3; Doxal-d3
EINECS	Contact for details

Quality Control

Every batch of Doxepin-D3 Hcl (n-Methyl-D3) is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, supported by comprehensive analytical data including NMR (1H, 13C), mass spectrometry, and HPLC. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, isotopic enrichment, and confirming the absence of unlabeled impurities. Our quality commitment aligns with the standards expected for pharmaceutical reference standards and materials used in GLP/GMP environments.

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 compound is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccant in the container. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0% (chemical purity)
Isotopic Purity	≥98.0 atom % D
Isotopic Enrichment	≥99.0% (by MS)
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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