Description

Tofacitinib Diastereomer Impurity product with CAS: is also known as 3-[(3RS, 4SR)-4-Methyl-3- [ methyl (7H-pyrrolo [2,3-d] pyrimidin-4-yl) amino] piperidin-1-yl]-3-oxopropanenitrile. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. It is used in Tofacitinib impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 3-[(3RS, 4SR)-4-Methyl-3- [ methyl (7H-pyrrolo [2,3-d] pyrimidin-4-yl) amino] piperidin-1-yl]-3-oxopropanenitrile 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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