Daclatasvir

Daclatasvir Impurities

Daclatasvir is a direct-acting antiviral agent used in combination therapy for the treatment of chronic hepatitis C virus (HCV) infection. Its impurity profile includes structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. Degradation pathways typically involve cleavage of the amide bonds, oxidation of the aromatic rings, and breakdown of the pyrimidine and quinoline moieties. These impurities may affect the drug’s potency, stability, and safety. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Daclatasvir EP Impurities

Pharmacopeial and non-pharmacopeial Daclatasvir impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and long-term stability studies. EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.

Daclatasvir Related Compounds

Structurally related compounds and synthetic analogs associated with Daclatasvir are included for use in impurity identification, toxicological qualification, and regulatory submission. These related substances are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations. They are essential for understanding the impurity profile and ensuring compliance with regulatory limits.

Daclatasvir Impurity Reference Standards

Daclatasvir 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.