Velpatasvir is a direct-acting antiviral agent that is used in combination therapy for chronic hepatitis C infection. Its impurity profile includes structurally related analogs, residual solvents, and degradation products. These products may be formed under stress conditions such as hydrolysis, oxidation, and photolysis. Typical degradation pathways involve oxidative breakdown of the heteroaromatic rings, hydrolytic cleavage of amide bonds, and rearrangement of substituents within the macrocyclic structure. These impurities may affect the potency, stability, and safety of the drug. Hence, all impurities are structurally characterized and qualified according to ICH guidelines for toxicological assessment and analytical validation.
Pharmacopeial and non-pharmacopeial Velpatasvir 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.
Structurally related compounds and synthetic analogs associated with Velpatasvir are included for 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.
Velpatasvir 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.
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