Aztreonam

Aztreonam Impurities

Aztreonam impurities consist of process-related substances, residual solvents, and degradation products that can form during synthesis or under stress conditions such as hydrolysis, oxidation, or photolysis. As a monobactam antibiotic used primarily against Gram-negative bacterial infections, Aztreonam requires stringent impurity profiling to ensure therapeutic efficacy and patient safety. Degradation pathways typically involve hydrolytic cleavage of the beta-lactam ring and oxidative modifications of the sulfonic acid or aminothiazole moieties. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Aztreonam EP Impurities

Pharmacopeial and non-pharmacopeial Aztreonam 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.

Aztreonam Related Compounds

Structurally related compounds and synthetic analogs associated with Aztreonam 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.

Aztreonam Impurity Reference Standards

Aztreonam 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.