Description

Roflumilast CAS NO 74976-40-2 is a selective, long-acting inhibitor of phosphodiesterase 4 (PDE4), representing a significant advancement in targeted anti-inflammatory therapy. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacture of innovative respiratory medications. It is primarily required by pharmaceutical companies and research institutions focused on treating chronic obstructive pulmonary disease (COPD) and other inflammatory conditions.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of prescription medications for the treatment of severe COPD.
• Clinical Research: Used in preclinical and clinical studies to investigate new therapeutic applications and formulations.
• Drug Development: Serves as a key reference standard and building block in the R&D of novel PDE4 inhibitors.
• Generic Drug Manufacturing: Essential for the production of generic versions of approved roflumilast-based drugs.
• Analytical Standard: High-purity grade material for use in quality control laboratories for HPLC, LC-MS, and other analytical methods.

Basic Information

Product Name	Roflumilast
CAS No.	74976-40-2
Molecular Formula	C17H14Cl2F2N2O3
Molecular Weight	403.21 g/mol
Synonyms	3-(Cyclopropylmethoxy)-N-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)benzamide; APTA 2217; B9302-107; BY 217; BYK 20869; Daliresp; Daxas
EINECS	Contact for details

Quality Control

Our Roflumilast is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with every shipment. We adhere to cGMP guidelines where applicable to support our global clientele in regulated markets.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.10%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤0.5%
Heavy Metals	≤20 ppm

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