Ranolazine

Ranolazine Impurities

Ranolazine impurities include process-related compounds, synthetic intermediates, degradation products, and nitrosamine contaminants that may arise during synthesis, formulation, or storage. As an anti-anginal agent that inhibits late sodium current (INa) in cardiac cells, 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.

Ranolazine EP Impurities

Pharmacopeial and non-pharmacopeial Ranolazine 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.

Ranolazine Related Compounds

Structurally related compounds and synthetic analogs associated with Ranolazine 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.

Ranolazine Impurity Reference Standards

Ranolazine 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.