Description

N,N-Dimethyl Tadalafil Impurity product with CAS: NA is also known as (2R)-2-(1,3-Dioxa-5-indanyl)-6,17-dimethyl-3.6.17-triazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. N,N-Dimethyl Tadalafil Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Tadalafil and its related formulations. Moreover, (2R)-2-(1,3-Dioxa-5-indanyl)-6,17-dimethyl-3.6.17-triazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione 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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