Description

Roflumilast-D3 CAS NO 1189992-00-4 is a deuterated analog of the active pharmaceutical ingredient roflumilast, a selective phosphodiesterase-4 (PDE4) inhibitor. This stable isotope-labeled compound is an essential tool for quantitative bioanalytical studies, enabling precise pharmacokinetic and metabolic profiling. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and academic institutions engaged in advanced drug development and regulatory submission processes.

Application

• Primary use as an internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) for the accurate quantification of roflumilast in biological matrices.
• Critical component in pharmacokinetic (PK) and bioavailability studies to determine drug absorption, distribution, metabolism, and excretion (ADME).
• Facilitates metabolite identification and profiling in drug metabolism studies due to its isotopic signature.
• Enhances data reliability in clinical trial analysis and supports regulatory filings to agencies like the FDA and EMA.
• Used in method development and validation for bioanalytical assays, ensuring precision and compliance with GLP guidelines.
• Applied in doping control analysis and forensic toxicology for specific detection protocols.

Basic Information

Product Name	Roflumilast-D3
CAS No.	1189992-00-4
Molecular Formula	C17H11D3Cl2F3N2O4
Molecular Weight	~ 420.25 g/mol
Synonyms	3-(Cyclopropylmethoxy)-N-(3,5-dichloro-1-oxopyridin-4-yl)-4-(difluoromethoxy)-2-(trideuteriomethyl)benzamide; 4-[[3-(Cyclopropylmethoxy)-4-(difluoromethoxy)-2-(trideuteriomethyl)phenyl]carbonyl]amino]-3,5-dichloropyridine 1-oxide; Roflumilast (methyl-d3); Roflumilast-d3; Deuterated Roflumilast; Roflumilast Internal Standard; [2H3]-Roflumilast
EINECS	Contact for details

Quality Control

Our Roflumilast-D3 is manufactured under strict quality systems to ensure high isotopic purity and chemical integrity, suitable for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing isotopic enrichment, chemical purity, and identity confirmation via advanced spectroscopic methods. We adhere to relevant industry standards for stable isotope-labeled compounds, ensuring reliable and reproducible performance in your critical research.

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 product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (deuterium)	≥ 99.0 atom % D
Chemical Purity (HPLC)	≥ 99.0%
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.