Description

n-Methyl Duloxetine-D7 is a deuterated analog of the active pharmaceutical ingredient duloxetine, specifically labeled with seven deuterium atoms on the n-methyl group. This compound serves as a critical internal standard in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory bodies involved in the development and quality control of duloxetine-based therapeutics.

Application

• Primary use as a stable isotope-labeled internal standard for the quantification of duloxetine and its metabolites in biological matrices via LC-MS/MS and GC-MS.
• Facilitates method development and validation for bioequivalence and bioavailability studies of generic duloxetine formulations.
• Enables precise pharmacokinetic profiling in clinical trials, improving data integrity for regulatory submissions.
• Supports advanced drug metabolism and pharmacokinetics (DMPK) research to elucidate metabolic pathways.
• Used in forensic and anti-doping analysis for the accurate detection of duloxetine.
• Critical for quality control in pharmaceutical manufacturing to monitor potential impurities or degradation products.

Basic Information

Item	Detail
Product Name	n-Methyl Duloxetine-D7
CAS No.	1217657-97-0
Molecular Formula	C18H12D7NO
Molecular Weight	Contact for details
Synonyms	(+)-(S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine-D7; Duloxetine N-Methyl-D7; N-Methyl Duloxetine-d7; LY248686-D7; (S)-N-Methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine-d7; Cymbalta-d7 (labeled analog); Ariclaim-d7 (labeled analog); Yentreve-d7 (labeled analog)
EINECS	Contact for details

Quality Control

Our n-Methyl Duloxetine-D7 is manufactured under strict quality systems to ensure exceptional isotopic purity and chemical integrity, suitable for the most demanding analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic purity (≥99% D), chemical purity (by HPLC), and confirmation of structure (by NMR and MS). We adhere to relevant industry standards for reference materials.

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 material 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 (NMR)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity	≥99.0 atom % D
Water Content (KF)	≤0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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