Tolvaptan

Tolvaptan Impurities

Tolvaptan impurities include synthetic intermediates, process-related compounds, degradation products, and potential nitrosamine contaminants that may arise during synthesis, formulation, or storage. As a selective vasopressin V2 receptor antagonist used to treat hyponatremia and autosomal dominant polycystic kidney disease (ADPKD), 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.

Tolvaptan EP Impurities

Pharmacopeial and non-pharmacopeial Tolvaptan 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.

Tolvaptan Related Compounds

Structurally related compounds and synthetic analogs associated with Tolvaptan 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.

Tolvaptan Impurity Reference Standards

Tolvaptan 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.