Description

4-(Cyclopropylmethoxy)-3-(Difluoromethoxy) Roflumilast is a key pharmaceutical intermediate and the primary metabolite of the active drug substance Roflumilast. This compound is of significant commercial importance in the development and manufacturing of advanced respiratory medications. It is primarily required by pharmaceutical R&D laboratories and API (Active Pharmaceutical Ingredient) manufacturers focused on producing treatments for chronic obstructive pulmonary disease (COPD) and severe asthma.

Application

• Primary Intermediate in the synthesis of the PDE4 inhibitor, Roflumilast.
• Reference Standard for analytical method development and validation in pharmaceutical quality control laboratories.
• Metabolite Studies for pharmacokinetic and pharmacodynamic research during drug development.
• Process Chemistry for scaling up and optimizing the manufacturing route for the final API.
• Impurity Profiling as a known metabolite to be monitored in stability studies and final product specifications.
• Regulatory Submissions, providing critical data for drug master files (DMFs) and investigational new drug (IND) applications.

Basic Information

Product Name	4-(Cyclopropylmethoxy)-3-(Difluoromethoxy) Roflumilast
CAS No.	162401-43-6
Molecular Formula	C17H14Cl2F2N2O3
Molecular Weight	403.21 g/mol
Synonyms	Roflumilast Metabolite; Roflumilast Impurity; 3-(Cyclopropylmethoxy)-4-(difluoromethoxy)-N-(3,5-dichloropyridin-4-yl)benzamide; 4-(Cyclopropylmethoxy)-3-(difluoromethoxy)-N-(3,5-dichloropyridin-4-yl)benzamide; BY-217 Metabolite; B9302-107; UNII-9I0K0405VU
EINECS	Contact for details

Quality Control

Our 4-(Cyclopropylmethoxy)-3-(Difluoromethoxy) Roflumilast is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets the stringent requirements for pharmaceutical intermediates. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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