Sofosbuvir Impurities

Sofosbuvir Impurities EP (USP Related Compounds)

Please find list of Sofosbuvir impurities offered by SynThink :

Synthink Research Chemicals is a producer and supplier of Sofosbuvir Impurities which are required for pharmaceutical companies to study quality, stability and biological safety of pharmaceutical products as well as HPLC method validation. All Sofosbuvir impurities are provided with certificate of analysis (CoA) along with the comprehensive characterization data like 1H-NMR, IR, MASS, HPLC Purity etc. On request, we also provide additional data like 13C-NMR, 13C-DEPT, CHN, TGA, etc (with extra charge/fees). SynThink provides various Sofosbuvir pharmacopeial and non-pharmacopeial Impurites including – Degradation Impurities, Process Impurities, Potential Impurities, API impurities etc.
Sofosbuvir was approved under the trade name Sovaldi® by the U.S. Food and Drug Administration (FDA) in December 2013 and by the European Commission in January 2014. Several companies granted exclusive license to produce generic sofosbuvir and investigational single tablet regimen of ledipasvir/sofosbuvir for treatment of chronic hepatitis C. Such exclusive license is believed to be essential for successful implementation of humanitarian program in developing countries.
We produce / manufacture all impurities using reliable scientific processes / techniques like organic synthesis techniques, enrichment and isolation by chromatography techniques, degradation and isolation process, etc. Sofosbuvir impurities produced by Synthink Research Chemicals can be used for monitoring acquiring and evaluating data that establishes quality, stability and biological safety of pharmaceutical products.

Sofosbuvir impurities produced by Synthink Research Chemicals can be used for ANDA filling/DMF filling, genotoxicity studies and other R&D studies like method validation etc.. Sofosbuvir impurities provided by SynThink can also be used as raw material to make your own internal / working standards. These impurities can also be used for spiking studies as well as for quality assurance (QA) during commercial production of Sofosbuvir.

In many cases when required impurities found in a pharmaceutical product are not available anywhere, needs to b custom synthesized. In such cases clients need to send the details of the required product to SynThink.

We are completely aware that impurities in pharma product is always a matter of worry within different departments of a pharmaceutical company. So, at SynThink we are committed to synthesize and characterize required Pharmacopial and non-pharmacopial Reference Standards, API Impurities as well as other working standards in a timely manner. Please feel free to request a quote from us.

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