Description

Roflumilast n-Oxide CAS NO 292135-78-5 is a key pharmaceutical intermediate and the primary active metabolite of the anti-inflammatory drug Roflumilast. This compound is of significant commercial and research interest due to its role in the development and quality control of treatments for chronic obstructive pulmonary disease (COPD). It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in drug development, metabolite studies, and reference standard production.

Application

• Pharmaceutical Intermediate: Critical for the synthesis and quality control of the active pharmaceutical ingredient (API) Roflumilast.
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for HPLC, LC-MS, and other chromatographic methods to quantify and qualify drug substances and products.
• Metabolite Research: Essential for pharmacokinetic and pharmacodynamic studies to understand the metabolism, efficacy, and safety profile of Roflumilast.
• Impurity Standard: Serves as a specified impurity standard in the stability testing and release of Roflumilast drug products to ensure compliance with ICH guidelines.
• Biochemical Research: Utilized in vitro studies to investigate the mechanism of action of PDE4 inhibitors and their effects on inflammatory pathways.
• Regulatory Submissions: Supplied to support drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) with regulatory bodies like the FDA and EMA.

Basic Information

Item	Details
Product Name	Roflumilast n-Oxide
CAS No.	292135-78-5
Molecular Formula	C17H14Cl2F2N2O3
Molecular Weight	403.21 g/mol
Synonyms	3-(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)benzamide N-oxide; Roflumilast Metabolite; Roflumilast N-Oxide; Roflumilast Impurity; BY217 N-Oxide; 3-(Cyclopropylmethoxy)-4-(difluoromethoxy)-N-(3,5-dichloro-4-pyridinyl)benzamide 1-oxide; APO 411
EINECS	Contact for details

Quality Control

Our Roflumilast n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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