Nitrofurantoin

Nitrofurantoin Impurities

Nitrofurantoin impurities include fermentation by-products, process-related compounds, and degradation products that may arise during synthesis, formulation, or storage. As a nitrofuran-class antibacterial agent used primarily for urinary tract infections, impurity profiling is essential to ensure product safety, therapeutic efficacy, and regulatory compliance. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Nitrofurantoin EP Impurities

Pharmacopeial and non-pharmacopeial Nitrofurantoin 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.

Nitrofurantoin Related Compounds

Structurally related compounds and biosynthetic analogs associated with Nitrofurantoin are included for use in impurity identification, toxicological qualification, and regulatory submission. These materials are thoroughly characterized and conform to international standards.

Nitrofurantoin Impurity Reference Standards

Nitrofurantoin impurity reference standards are provided with validated analytical data including purity, NMR, and MS. 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.