Pitavastatin

Pitavastatin Impurities

Pitavastatin impurities include process-related compounds, synthetic intermediates, and degradation products that may arise during synthesis, formulation, or storage. As an HMG-CoA reductase inhibitor used to manage hypercholesterolemia and reduce cardiovascular risk, 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.

Pitavastatin EP Impurities

Pharmacopeial and non-pharmacopeial Pitavastatin 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.

Pitavastatin Related Compounds

Structurally related compounds and synthetic analogs associated with Pitavastatin 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.

Pitavastatin Impurity Reference Standards

Pitavastatin 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.