Azelastine

Azelastine Impurities

Azelastine impurities include synthetic intermediates, process-related compounds, degradation products, and residual solvents that may arise during synthesis, formulation, or storage. As a selective histamine H₁-receptor antagonist used in the treatment of allergic rhinitis and conjunctivitis, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. Known degradation pathways include hydrolysis and photolytic breakdown, particularly under UV exposure. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Azelastine EP Impurities

Pharmacopeial and non-pharmacopeial Azelastine 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.

Azelastine Related Compounds

Structurally related compounds and synthetic analogs associated with Azelastine 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.

Azelastine Impurity Reference Standards

Azelastine 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.