1-Hydroxy Ertugliflozin Impurity
| CAS No. | : NA |
| Mol F. | : C22H27ClO8 |
| Mol W. | : 454.9 |
| Cat No. | : SA36810 |
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Description
| Product Name | 1-Hydroxy Ertugliflozin Impurity |
| Synonyms | (2S,3R,4S,5S)-2-{4-Chloro-3-[(p-ethoxyphenyl)methyl]phenyl}-6,6-bis(hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetrol |
| Related API | Ertugliflozin |
| Category | Impurities |
1-Hydroxy Ertugliflozin Impurity product with CAS: NA is also known as (2S,3R,4S,5S)-2-{4-Chloro-3-[(p-ethoxyphenyl)methyl]phenyl}-6,6-bis(hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetrol; . This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). 1-Hydroxy Ertugliflozin Impurity is used in Ertugliflozin impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Ertugliflozin and its related formulations. Moreover, (2S,3R,4S,5S)-2-{4-Chloro-3-[(p-ethoxyphenyl)methyl]phenyl}-6,6-bis(hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetrol is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation. Please also find out other impurities of Ertugliflozin developed in our R&D.
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