Description

Nintedanib Nitroso Impurity 1 product with CAS: is also known as (Z)-methyl-3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)(nitroso)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate; . 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 compound is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Nintedanib and its related formulations. Moreover, (Z)-methyl-3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)(nitroso)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation. Please also find out other impurities of Nintedanib developed in our R&D.

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