Ketoconazole

Ketoconazole Impurities

Ketoconazole impurities include synthetic intermediates, process-related compounds, degradation products, and residual solvents that may arise during synthesis, formulation, or storage. As an imidazole antifungal agent used in the treatment of systemic and topical fungal infections, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. Known degradation pathways include hydrolysis and oxidative breakdown, particularly under acidic or photolytic conditions. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Ketoconazole EP Impurities

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

Ketoconazole Related Compounds

Structurally related compounds and synthetic analogs associated with Ketoconazole are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Ketoconazole Impurity Reference Standards

Ketoconazole 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.