Description

(±)-Duloxetine-D5 Oxalate (n-Methyl-Dj Propanamine-D2) is a deuterated analog of the active pharmaceutical ingredient duloxetine, specifically labeled for use as an internal standard in analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and bioequivalence studies. It is a critical tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and quality control departments requiring precise measurement of duloxetine in complex biological matrices.

Application

• Internal Standard for LC-MS/MS: Primary use as a stable, isotopically labeled internal standard for the quantification of duloxetine in plasma, serum, and other biological samples using liquid chromatography-tandem mass spectrometry.
• Pharmacokinetic Research: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in clinical and pre-clinical studies.
• Bioanalytical Method Development & Validation: Serves as a critical reference material for developing, validating, and troubleshooting high-sensitivity analytical methods in compliance with FDA and ICH guidelines.
• Drug Metabolism Studies: Used in metabolite identification and profiling studies to distinguish drug-derived compounds from endogenous substances.
• Quality Control & Assurance: Supports impurity profiling and assay verification of duloxetine active pharmaceutical ingredient (API) and finished dosage forms.
• Forensic & Toxicology Analysis: Aids in the precise determination of duloxetine concentrations in forensic and toxicological investigations.

Basic Information

Product Name	(±)-Duloxetine-D5 Oxalate (n-Methyl-Dj Propanamine-D2)
CAS No.	116817-14-2
Molecular Formula	C18H14D5NO • C2H2O4
Molecular Weight	Contact for details
Synonyms	Duloxetine-d5 Oxalate; (+-)-Duloxetine-d5 Oxalate; N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine-d5 Oxalate; LY248686-d5 Oxalate; Cymbalta-d5 (deuterated analog); (S)-N-Methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)-1-propanamine-d5 Oxalate; (R)-N-Methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)-1-propanamine-d5 Oxalate; n-Methyl-Dj Propanamine-D2 Oxalate.
EINECS	Contact for details

Quality Control

Every batch of (±)-Duloxetine-D5 Oxalate is manufactured and tested under strict quality systems. We guarantee high chemical and isotopic purity, confirmed by advanced spectroscopic and chromatographic techniques including NMR, HPLC, and MS. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, isotopic enrichment, and solvent content. Our quality commitment supports compliance with ICH Q7 and cGMP standards for pharmaceutical reference materials.

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. For long-term storage, consider desiccant use and storage under 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-content)	≥ 98.0 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.