Agomelatine

Agomelatine Impurities

Agomelatine impurities consist of process-related compounds, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. As an atypical antidepressant acting as a melatonergic agonist and serotonin antagonist, impurity profiling is essential to maintain therapeutic efficacy and patient safety. Degradation pathways typically involve hydrolytic cleavage of the acetamide group and oxidative breakdown of the naphthalene ring system under acidic or photolytic conditions. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Agomelatine EP Impurities

Pharmacopeial and non-pharmacopeial Agomelatine 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.

Agomelatine Related Compounds

Structurally related compounds and synthetic analogs associated with Agomelatine 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.

Agomelatine Impurity Reference Standards

Agomelatine 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.