Amikacin

Amikacin Impurities

Amikacin impurities include fermentation by-products, synthetic intermediates, process-related compounds, degradation products, and residual solvents that may arise during biosynthesis, formulation, or storage. As a semi-synthetic aminoglycoside antibiotic derived from kanamycin A, used to treat severe Gram-negative bacterial infections, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. Known degradation pathways include hydrolysis and oxidative cleavage, particularly under acidic or high-temperature conditions. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Amikacin EP Impurities

Pharmacopeial and non-pharmacopeial Amikacin impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and stability testing. EP traceable materials are supplied with validated analytical data including purity, structural confirmation, and spectral characterization.

Amikacin Related Compounds

Structurally related compounds and biosynthetic analogs associated with Amikacin are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards. Related compounds are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations.

Amikacin Impurity Reference Standards

Amikacin 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.