Benzalkonium Chloride

Benzalkonium Chloride Impurities

Benzalkonium Chloride impurities include synthetic intermediates, homologous alkyl chain variants, process-related compounds, degradation products, and residual solvents that may arise during synthesis, formulation, or storage. As a quaternary ammonium compound widely used as a preservative, disinfectant, and antiseptic in pharmaceutical and personal care products, impurity profiling is essential to ensure product safety, antimicrobial efficacy, and regulatory compliance. Known degradation pathways include hydrolysis and oxidative cleavage, particularly under light and elevated temperature conditions. All impurity compounds are structurally characterized and qualified under ICH guidelines for toxicological evaluation and analytical validation.

Benzalkonium Chloride EP Impurities

Pharmacopeial and non-pharmacopeial Benzalkonium Chloride 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.

Benzalkonium Chloride Related Compounds

Structurally related compounds and homologous series members associated with Benzalkonium Chloride 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.

Benzalkonium Chloride Impurity Reference Standards

Benzalkonium Chloride 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.