(1R, 3R) N-Methyl Amide Tadalafil Impurity
CAS No. | : NA |
Mol F. | : C20H19N3O3 |
Mol W. | : 349.38 |
Cat No. | : SA20910 |
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Description
Product Name | (1R, 3R) N-Methyl Amide Tadalafil Impurity |
Synonyms | [(1R,3R)-1-(1,3-Dioxa-5-indanyl)-2,3,4,9-tetrahydro-1H-β-carbolin-3-yl](methylamino)formaldehyde
(1R,3R)-methyl-1,2,3,4-tetrahydro-1-(3,4-methylenedioxyphenyl)-9H-pyrido[3,4-b]indole-3-carboxamide |
Related API | Tadalafil |
Category | Impurities |
(1R, 3R) N-Methyl Amide Tadalafil Impurity product with CAS: NA is also known as [(1R,3R)-1-(1,3-Dioxa-5-indanyl)-2,3,4,9-tetrahydro-1H-β-carbolin-3-yl](methylamino)formaldehyde. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. (1R, 3R) N-Methyl Amide Tadalafil Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Tadalafil and its related formulations. Moreover, [(1R,3R)-1-(1,3-Dioxa-5-indanyl)-2,3,4,9-tetrahydro-1H-β-carbolin-3-yl](methylamino)formaldehyde 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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