Leflunomide EP Impurity B
|CAS No.||: 163451-81-8(ZIsomer),108605-62-5(E/ZMixture)|
|Mol F.||: C12H9F3N2O2|
|Mol W.||: 270.21|
|Cat No.||: SA21802|
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|Product Name||Leflunomide EP Impurity B|
Leflunomide USP RC B
Cyano Keto leflunomide impurity
Leflunomide EP Impurity B product with CAS: 163451-81-8(ZIsomer),108605-62-5(E/ZMixture) is related to Leflunomide. It is also known with other names such as Teriflunomide; Leflunomide USP RC B. This product is developed by SynThink’s R&D team using various organic synthesis and analytical techniques. It is used in monitoring and controlling of impurity levels in Leflunomide and its related formulations as per International Conference on Harmonization (ICH) formulated guidelines. Moreover, Teriflunomide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.
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Certificate of Analysis (CoA) and Characterization Data:
All products are provided with a certificate of analysis (CoA) along with the characterization data like 1H-NMR, MASS, HPLC Purity, MSDS, etc. (whatever relevant and possible). Moreover, additional data like 13C-NMR, 13C-DEPT NMR, GC, GC-MS, IC, Potency, TGA, etc. will be provided on request (extra charges may apply).
This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. This product provided by SynThink is generally used for Abbreviated New Drug Application (ANDA) filing to FDA, toxicity study of respective drug formulation, Quality Control (QC) and analytical studies during commercial production of the API]. Please also find out process impurities, degradation impurities, potential impurities of related api/drug developed by our R&D.
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