Acemetacin

Acemetacin Impurities

Acemetacin is a glycolic acid ester of indometacin and belongs to the non-steroidal anti-inflammatory drug (NSAID) class. 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 hydrolytic cleavage of the ester bond and oxidative breakdown of the indole ring system. These impurities may impact the drug’s stability and pharmacological activity. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Acemetacin EP Impurities

Pharmacopeial and non-pharmacopeial Acemetacin 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.

Acemetacin Related Compounds

Structurally related compounds and synthetic analogs associated with Acemetacin 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.

Acemetacin Impurity Reference Standards

Acemetacin 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.