Description

Amitriptyline-13C3 Hydrochloride is a stable isotope-labeled analog of the tricyclic antidepressant amitriptyline, specifically labeled with three carbon-13 atoms. This compound is an essential internal standard for the precise and accurate quantification of amitriptyline in complex biological matrices using advanced analytical techniques. It is primarily required by pharmaceutical R&D laboratories, clinical research organizations, and forensic toxicology units engaged in method development, pharmacokinetic studies, and therapeutic drug monitoring.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard in LC-MS/MS and GC-MS methods for the quantification of amitriptyline and its metabolites in plasma, serum, and urine.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in preclinical and clinical research.
• Therapeutic Drug Monitoring (TDM): Used to calibrate assays that ensure patient drug levels remain within the therapeutic window, optimizing efficacy and minimizing side effects.
• Forensic and Clinical Toxicology: Essential for confirmatory testing and accurate measurement in cases of overdose, poisoning, or post-mortem investigations.
• Drug Metabolism and Disposition Studies: Facilitates the identification and quantification of metabolite profiles generated from the parent drug.
• Method Development and Validation: Provides a stable, non-interfering reference point for developing robust, sensitive, and selective analytical methods compliant with GLP guidelines.
• Reference Standard for Quality Control: Used in the quality control of pharmaceutical formulations to ensure batch consistency and potency.

Basic Information

Product Name	Amitriptyline-13C3 Hydrochloride
CAS No.	1329837-86-6
Molecular Formula	C20H23N•HCl (with three 13C atoms)
Molecular Weight	~287.9 g/mol (13C labeled)
Synonyms	10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptene-δ5,γ-propylamine-13C3 hydrochloride; 3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine-13C3 hydrochloride; Amitriptyline-13C3 HCl; 13C3-Amitriptyline Hydrochloride; Labeled Amitriptyline HCl; Isotopic Internal Standard for Amitriptyline
EINECS	Contact for details

Quality Control

Every batch of Amitriptyline-13C3 Hydrochloride is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including isotopic purity and chemical purity assays, to ensure compliance with the high standards required for analytical research. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, purity (by HPLC), isotopic enrichment, and related substances is provided with each shipment.

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 should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to expected mass spectrum
Purity (HPLC)	≥98.0%
Isotopic Purity (13C3)	≥99 atom % 13C
Chemical Purity	≥95%
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.