Description

Roflumilast CAS NO 162401-32-3 is a selective, long-acting inhibitor of phosphodiesterase 4 (PDE4) with potent anti-inflammatory properties. This active pharmaceutical ingredient (API) is critical for the development and manufacturing of advanced respiratory therapeutics. It is primarily required by pharmaceutical companies and research institutions focused on treating chronic obstructive pulmonary disease (COPD) and other inflammatory airway conditions.

Application

• Pharmaceutical API: Primary active ingredient in prescription medications for the maintenance treatment of severe COPD.
• Clinical Research: Used in preclinical and clinical studies investigating new therapeutic applications for PDE4 inhibition.
• Formulation Development: Serves as the key component in the development of solid oral dosage forms, such as tablets.
• Reference Standard: Utilized as a high-purity analytical standard in quality control laboratories for method development and validation.
• Biochemical Research: A tool compound for studying PDE4 enzyme activity and intracellular cAMP signaling pathways in inflammatory cells.

Basic Information

Product Name	Roflumilast
CAS No.	162401-32-3
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; Daxas; Daliresp; Zafirelix; PDE4 Inhibitor
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 stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) confirming compliance with relevant pharmacopeial standards (e.g., USP, EP) are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to maintain stability.

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% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.