Description

Doxofylline is a selective phosphodiesterase (PDE) inhibitor belonging to the xanthine class of compounds, recognized for its therapeutic bronchodilator effects. Its primary value lies in offering a favorable efficacy and safety profile compared to other methylxanthines, with reduced cardiovascular and central nervous system side effects. This makes it a critical active pharmaceutical ingredient (API) for manufacturers developing respiratory medications targeting conditions such as asthma and chronic obstructive pulmonary disease (COPD).

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the formulation of oral solid dosage forms like tablets and capsules.
• Key component in anti-asthmatic drugs for the management and prevention of bronchospasm.
• Essential for producing medications for Chronic Obstructive Pulmonary Disease (COPD) to improve lung function.
• Used in clinical research and reference standard development for analytical and pharmacological studies.
• Potential ingredient in veterinary respiratory therapeutics for analogous conditions in animals.
• Intermediate in advanced pharmaceutical synthesis for novel xanthine derivatives.

Basic Information

Product Name	Doxofylline
CAS No.	69975-86-6
Molecular Formula	C11H14N4O4
Molecular Weight	266.25 g/mol
Synonyms	7-(1,3-Dioxolan-2-ylmethyl)-1,3-dimethylpurine-2,6-dione; Doxophylline; Ansimar; Doxofilina; Doxophyllinum; Doxofilinum; Doxophylline; Doxofilina [INN-Spanish]
EINECS	Contact for details

Quality Control

Our Doxofylline is manufactured under strict quality systems to ensure it meets the high standards required for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identification, assay, and impurity profiling via HPLC and other pharmacopeial methods. We provide full traceability and support our customers with detailed Certificates of Analysis (COA) and regulatory documentation (e.g., DMF) to facilitate seamless integration into your supply chain.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Microbial Limits	Conforms to EP/USP requirements

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