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Umifenovir (commonly known as Arbidol) is a broad-spectrum antiviral agent that is used in the treatment and prevention of influenza and other viral infections. Its impurity profile includes structurally related analogs, residual solvents, and degradation products. These impurities may originate from stress conditions such as hydrolysis, oxidation, and photolysis. Typical degradation pathways of Umifenovir involve oxidative breakdown of the indole ring, hydrolytic cleavage of ester bonds, and rearrangement of substituents within the aromatic scaffold. These impurities may affect the potency, stability, and safety of the drug. Thus, all impurities are structurally characterized and qualified according to ICH guidelines for toxicological assessment and analytical validation.
We provide pharmacopeial and non-pharmacopeial Umifenovir impurity compounds that are available in compliance with European Pharmacopoeia (EP) specifications. These standards can be used for supporting of analytical method development, impurity profiling, and long-term stability studies. Therefore, EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.
Structurally related compounds and synthetic analogs of Umifenovir 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.
We provide Umifenovir impurity reference standards that are available 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. We synthesize EP/USP traceable impurities that are available upon request and are routinely re-tested to ensure consistency and reliability.
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