Simvastatin

Simvastatin Impurities

Simvastatin impurities include synthetic intermediates, process-related compounds, degradation products, and potential nitrosamine contaminants that may arise during synthesis, formulation, or storage. As an HMG-CoA reductase inhibitor used to lower cholesterol 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.

Simvastatin EP Impurities

Pharmacopeial and non-pharmacopeial Simvastatin 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.

Simvastatin Related Compounds

Structurally related compounds and synthetic analogs associated with Simvastatin 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.

Simvastatin Impurity Reference Standards

Simvastatin 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.