Penicillin

Penicillin Impurities

Penicillin 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 β-lactam antibiotic derived from Penicillium species and used to treat a wide range of bacterial infections, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. Known degradation pathways include hydrolysis of the β-lactam ring and oxidative breakdown under acidic, basic, or thermal stress conditions. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Penicillin EP Impurities

Pharmacopeial and non-pharmacopeial Penicillin 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.

Penicillin Related Compounds

Structurally related compounds and biosynthetic analogs associated with Penicillin 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.

Penicillin Impurity Reference Standards

Penicillin 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.