Description

2-Hydroxy Trimipramine-D3 is a stable isotope-labeled analog of a key trimipramine metabolite, specifically designed for use as an internal standard in quantitative bioanalytical methods. This high-purity reference material is critical for ensuring the accuracy, precision, and regulatory compliance of pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities involved in drug development and forensic toxicology.

Application

• Internal Standard for LC-MS/MS: Essential for the precise quantification of 2-hydroxytrimipramine and related metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used to investigate the metabolic pathways, clearance rates, and bioavailability of trimipramine in preclinical and clinical research.
• Forensic and Clinical Toxicology: Enables accurate measurement of trimipramine and its metabolites for therapeutic drug monitoring (TDM) and in cases of suspected overdose.
• Pharmaceutical Impurity Profiling: Serves as a reference standard for identifying and quantifying potential degradants or metabolites in drug substance and product stability studies.
• Method Development and Validation: A key component in developing, optimizing, and validating robust analytical methods compliant with FDA, EMA, and ICH guidelines.

Basic Information

Product Name	2-Hydroxy Trimipramine-D3
CAS No.	1189647-53-7
Molecular Formula	C20H23D3N2O
Molecular Weight	313.45 g/mol
Synonyms	2-Hydroxytrimipramine-d3; Deuterated 2-Hydroxy Trimipramine; 5-[3-(Dimethylamino)-2-methylpropyl]-10,11-dihydro-2-hydroxy-5H-dibenzo[b,f]azepine-d3; Trimipramine Metabolite D3; 2-OH-Trimipramine-D3; 2-Hydroxy-10,11-dihydro-N,N,β-trimethyl-5H-dibenzo[b,f]azepine-5-propanamine-d3
EINECS	Contact for details

Quality Control

Every batch of 2-Hydroxy Trimipramine-D3 is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. We guarantee high chemical and isotopic purity, verified by advanced techniques including NMR, HPLC, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific data for identity, purity (HPLC), isotopic enrichment, and residual solvents, ensuring compliance with the stringent requirements of analytical reference standard applications.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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