Description

Amitriptyline-D3 HCl (n-Methyl-D3) is a deuterium-labeled analog of the tricyclic antidepressant amitriptyline, specifically labeled on the N-methyl group. This stable isotope-labeled compound is an essential internal standard for the precise and accurate quantification of amitriptyline 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 forensic toxicology labs engaged in drug metabolism and pharmacokinetics (DMPK) studies, therapeutic drug monitoring, and bioanalytical method development.

Application

• Bioanalytical Internal Standard: Serves as a critical internal standard in liquid chromatography-tandem mass spectrometry (LC-MS/MS) for the quantification of amitriptyline in plasma, serum, and urine.
• Pharmacokinetic & DMPK Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Therapeutic Drug Monitoring (TDM): Used in assays to monitor amitriptyline concentrations in patient samples to ensure therapeutic efficacy and avoid toxicity.
• Forensic & Clinical Toxicology: Facilitates accurate identification and quantification in overdose cases or post-mortem analyses.
• Metabolite Identification & Profiling: Aids in the structural elucidation and quantification of amitriptyline metabolites.
• Method Development & Validation: Essential for developing, optimizing, and validating robust, regulatory-compliant bioanalytical methods.
• Quality Control in Reference Material Production: Used in the calibration and verification of certified reference materials (CRMs).

Basic Information

Product Name	Amitriptyline-D3 HCl (n-Methyl-D3)
CAS No.	342611-00-1
Molecular Formula	C20H20D3ClN
Molecular Weight	316.88 g/mol
Synonyms	3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-(trideuteriomethyl)-1-propanamine Hydrochloride; Amitriptyline-(N-methyl-d3) Hydrochloride; 5-(3-Methylaminopropylidene)-10,11-dihydro-5H-dibenzo[a,d]cycloheptene-d3 Hydrochloride; N-Methyl-d3-Amitriptyline Hydrochloride; Amitriptyline D3 HCl; Deuterated Amitriptyline HCl; [N-Methyl-d3]-Amitriptyline Hydrochloride
EINECS	Contact for details

Quality Control

Our deuterated standards are manufactured under strict quality protocols to ensure the highest isotopic purity and chemical integrity required for sensitive analytical applications. Each batch of Amitriptyline-D3 HCl undergoes comprehensive analysis, including HPLC for chemical purity, NMR and MS for structural and isotopic confirmation. Certificates of Analysis (COA) detailing lot-specific results for assay, isotopic enrichment, and impurities are provided. We support compliance with GMP/GLP guidelines for research and regulatory submissions.

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) 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 (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (MS)	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
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.