Description

Duloxetine-D7 is a high-purity, stable isotope-labeled analog of the widely prescribed antidepressant and analgesic, duloxetine. This deuterated compound is an essential internal standard for the accurate quantification of duloxetine in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and forensic toxicology. The product ensures reliable and reproducible results critical for drug development and regulatory compliance.

Application

• Internal Standard for Bioanalysis: Serves as a critical reference standard in the quantitative LC-MS/MS analysis of duloxetine in plasma, serum, and urine for clinical and preclinical studies.
• Pharmacokinetic & Metabolism Research: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in development programs.
• Forensic and Clinical Toxicology: Used in confirmatory testing and method development for the accurate detection of duloxetine in forensic and diagnostic laboratories.
• Method Development and Validation: Essential for developing, optimizing, and validating robust analytical methods in compliance with FDA, EMA, and ICH guidelines.
• Quality Control in Manufacturing: Can be employed in impurity profiling and stability-indicating assay methods for duloxetine active pharmaceutical ingredient (API).
• Isotope Dilution Mass Spectrometry (IDMS): Provides the highest accuracy for absolute quantification in reference material characterization and high-value research.

Basic Information

Product Name	Duloxetine-D7
CAS No.	919514-01-5
Molecular Formula	C18H12D7NOS
Molecular Weight	304.45 g/mol
Synonyms	(+)-(S)-N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine-D7; (S)-Duloxetine-D7; LY248686-D7; Cymbalta-D7; N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine-D7; (S)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine-D7; Deuterated Duloxetine
EINECS	Contact for details

Quality Control

Every batch of Duloxetine-D7 is manufactured and analyzed under strict quality systems. We provide comprehensive Certificates of Analysis (COA) detailing purity, isotopic enrichment, and impurity profiles, ensuring traceability and compliance with research and regulatory standards. Our quality commitment aligns with the needs of analytical and pharmaceutical development, supporting method validation per ICH Q2(R1) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions. 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 Enrichment	≥ 98 atom % D
Chemical Purity (NMR)	Conforms
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 0.5%

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