Nitrosamine impurity for Formoterol fumarate dihydrate
CAS No. | : NA |
Mol F. | : C19H23N3O5 |
Mol W. | : 273.41 |
Cat No. | : SA44611 |
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Description
Product Name | Nitrosamine impurity for Formoterol fumarate dihydrate |
Synonyms | N-(2-hydroxy-5-((R)-1-hydroxy-2-(((R)-1-(4-methoxyphenyl)propan-2-yl)(nitroso)amino)ethyl)phenyl)formamide |
Related API | Nitrosamine |
Category | Impurities |
Nitrosamine impurity for Formoterol fumarate dihydrate product with CAS: NA is also known as N-(2-hydroxy-5-((R)-1-hydroxy-2-(((R)-1-(4-methoxyphenyl)propan-2-yl)(nitroso)amino)ethyl)phenyl)formamide. 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, N-(2-hydroxy-5-((R)-1-hydroxy-2-(((R)-1-(4-methoxyphenyl)propan-2-yl)(nitroso)amino)ethyl)phenyl)formamide 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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