Sacubitril

Sacubitril Impurities

Sacubitril impurities include synthetic intermediates, process-related compounds, degradation products, and potential nitrosamine contaminants that may arise during synthesis, formulation, or storage. As a neprilysin inhibitor used in combination with valsartan for the treatment of heart failure, 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.

Sacubitril EP Impurities

Pharmacopeial and non-pharmacopeial Sacubitril 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.

Sacubitril Related Compounds

Structurally related compounds and synthetic analogs associated with Sacubitril 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.

Sacubitril Impurity Reference Standards

Sacubitril 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.