Acrivastine

Acrivastine Impurities

Acrivastine impurities consist of structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. As a second-generation H1-receptor antagonist used to treat allergic conditions like hay fever and urticaria, impurity profiling is essential to maintain therapeutic efficacy and patient safety. Degradation pathways typically involve oxidative breakdown of the pyridine ring, hydrolytic cleavage of the acrylate ester, and isomerization of the double bonds. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Acrivastine EP Impurities

Pharmacopeial and non-pharmacopeial Acrivastine 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.

Acrivastine Related Compounds

Structurally related compounds and synthetic analogs associated with Acrivastine 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.

Acrivastine Impurity Reference Standards

Acrivastine 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.