Description

Roflumilast n-Oxide D4 is a deuterated analog of the primary active metabolite of the phosphodiesterase-4 (PDE4) inhibitor, roflumilast. This compound is a critical stable isotope-labeled internal standard used in quantitative bioanalytical methods, ensuring the highest accuracy and reliability in pharmacokinetic and metabolic studies. It is an essential tool for pharmaceutical R&D and clinical laboratories focused on respiratory and inflammatory diseases, where precise measurement of drug and metabolite concentrations is paramount.

Application

• Bioanalytical Internal Standard: Primary use as a deuterium-labeled internal standard for the precise quantification of roflumilast n-oxide in biological matrices (e.g., plasma, serum) via LC-MS/MS.
• Pharmacokinetic (PK) Studies: Enables accurate determination of absorption, distribution, metabolism, and excretion (ADME) profiles of roflumilast in preclinical and clinical trials.
• Metabolite Profiling & Quantification: Facilitates the specific identification and measurement of the active metabolite in complex biological samples, supporting drug metabolism and pharmacodynamics (DMPK) research.
• Method Development & Validation: Serves as a critical reference material for developing, optimizing, and validating robust analytical methods in compliance with GLP and FDA/EMA guidelines.
• Drug-Drug Interaction Studies: Used in studies investigating the potential impact of other drugs on the metabolism of roflumilast.
• Quality Control for Reference Standards: Can be utilized as a system suitability or calibration standard in analytical laboratories.

Basic Information

Product Name	Roflumilast n-Oxide D4
CAS No.	1794760-31-8
Molecular Formula	C17H10D4Cl2F3N2O4
Molecular Weight	419.22 g/mol
Synonyms	3-(Cyclopropylmethoxy)-N-(3,5-dichloro-1-oxido-4-pyridinyl)-4-(difluoromethoxy)benzamide-d4; 3-(Cyclopropylmethoxy)-4-(difluoromethoxy)-N-(3,5-dichloro-4-pyridinyl)benzamide N-Oxide-d4; Roflumilast N-Oxide-d4; Roflumilast Metabolite D4; BY217-d4; APTA 2217-d4; Deuterated Roflumilast N-Oxide; [²H₄]-Roflumilast N-Oxide
EINECS	Contact for details

Quality Control

Our stable isotope-labeled materials are produced and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including NMR, HPLC, and MS, to confirm chemical identity, isotopic purity (D-enrichment ≥98%), and chemical purity (typically ≥95%). Certificates of Analysis (COA) detailing all specifications and test results are provided to ensure full traceability and compliance with the rigorous standards required for bioanalytical and regulatory 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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant in the container.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC-MS)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Isotopic Purity (D-enrichment)	≥ 98 atom % D
Water Content (KF)	≤ 2.0%
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.