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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