Tadalafil N-Hydroxy Methyl impurity
| CAS No. | : NA |
| Mol F. | : C23H21N3O5 |
| Mol W. | : 419.43 |
| Cat No. | : SA20912 |
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Description
| Product Name | Tadalafil N-Hydroxy Methyl impurity |
| Synonyms | (2R)-2-(1,3-Dioxa-5-indanyl)-17-(hydroxymethyl)-6-methyl-3.6.17-triazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione |
| Related API | Tadalafil |
| Category | Impurities |
Tadalafil N-Hydroxy Methyl impurity product with CAS: NA is also known as (2R)-2-(1,3-Dioxa-5-indanyl)-17-(hydroxymethyl)-6-methyl-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. Tadalafil N-Hydroxy Methyl 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)-17-(hydroxymethyl)-6-methyl-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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