Nitrosamine impurity of Atorvastatin Calcium
| CAS No. | : NA |
| Mol F. | : C33H34FN3O6 |
| Mol W. | : 587.64 |
| Cat No. | : SA44613 |
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Description
| Product Name | Nitrosamine impurity of Atorvastatin Calcium |
| Synonyms | (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-4-(nitroso(phenyl)carbamoyl)-3-phenyl-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid |
| Related API | Nitrosamine |
| Category | Impurities |
Nitrosamine impurity of Atorvastatin Calcium product with CAS: NA is also known as (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-4-(nitroso(phenyl)carbamoyl)-3-phenyl-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid. 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 Nitrosamine impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-4-(nitroso(phenyl)carbamoyl)-3-phenyl-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid 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.
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