Sofosbuvir Impurity SA15436
| CAS No. | : NA |
| Mol F. | : C17H19N3O6 |
| Mol W. | : 361.35 |
| Cat No. | : SA15436 |
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Description
| Product Name | Sofosbuvir Impurity SA15436 |
| Synonyms | {(1R)-1-[(2R,3S,4R,5R)-3,4-Dihydroxy-5-(hydroxymethyl)-3-methyltetrahydrofur-2-yl]-2-oxo-1H-pyrimidin-4-ylamino}phenylformaldehyde |
| Related API | Sofosbuvir |
| Category | Impurities |
Sofosbuvir Impurity SA15436 product with CAS: NA is also known as {(1R)-1-[(2R,3S,4R,5R)-3,4-Dihydroxy-5-(hydroxymethyl)-3-methyltetrahydrofur-2-yl]-2-oxo-1H-pyrimidin-4-ylamino}phenylformaldehyde. 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 Sofosbuvir impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, {(1R)-1-[(2R,3S,4R,5R)-3,4-Dihydroxy-5-(hydroxymethyl)-3-methyltetrahydrofur-2-yl]-2-oxo-1H-pyrimidin-4-ylamino}phenylformaldehyde 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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