Etodolac

Etodolac Impurities

Etodolac is a non-steroidal anti-inflammatory drug (NSAID) used in the treatment of pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and other musculoskeletal conditions. Its impurity profile includes structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. Degradation pathways typically involve oxidative breakdown of the indole ring, hydrolytic cleavage of the carboxamide group, and rearrangement of the pyran moiety. These impurities may affect the drug’s potency, stability, and safety. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Etodolac EP Impurities

Pharmacopeial and non-pharmacopeial Etodolac 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.

Etodolac Related Compounds

Structurally related compounds and synthetic analogs associated with Etodolac 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.

Etodolac Impurity Reference Standards

Etodolac 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.