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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Certificate of Analysis (CoA) and Characterization Data:
All products are provided with a certificate of analysis (CoA) along with the characterization data like 1H-NMR, MASS, HPLC Purity, MSDS, etc. (whatever relevant and possible). Moreover, additional data like 13C-NMR, 13C-DEPT NMR, GC, GC-MS, IC, Potency, TGA, etc. will be provided on request (extra charges may apply).
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 product provided by SynThink is generally used for Abbreviated New Drug Application (ANDA) filing to FDA, toxicity study of respective drug formulation, Quality Control (QC) and analytical studies during commercial production of the API]. Please also find out process impurities, degradation impurities, potential impurities of related api/drug developed by our R&D.
Products provide by SynThink are for research and development (R&D) use only
If you need different pack size / quantity, please contact us or email us at [email protected]
Terms and Conditions
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