Doxofylline

Doxofylline Impurities

Doxofylline impurities consist of structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. As a methylxanthine derivative used in the treatment of asthma and chronic obstructive pulmonary disease (COPD), impurity profiling is essential to maintain therapeutic efficacy and patient safety. Degradation pathways typically involve hydrolytic cleavage of the dioxolane ring and oxidative modifications of the xanthine core. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Doxofylline EP Impurities

Pharmacopeial and non-pharmacopeial Doxofylline impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and long-term stability studies. EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.

Doxofylline Related Compounds

Structurally related compounds and synthetic analogs associated with Doxofylline are included for use in impurity identification, toxicological qualification, and regulatory submission. These related substances are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations. They are essential for understanding the impurity profile and ensuring compliance with regulatory limits.

Doxofylline Impurity Reference Standards

Doxofylline impurity reference standards are provided with validated analytical data, including purity, NMR, MS, and full Certificates of Analysis. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.