Deshydroxy Impurity (Formoterol Fumarate)

Deshydroxy Impurity (Formoterol Fumarate) product with CAS: 477552-93-5 is also known as (R)-N-(2-hydroxy-5-(2-((1-(4-methoxyphenyl)propan-2-yl)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 Formoterol impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (R)-N-(2-hydroxy-5-(2-((1-(4-methoxyphenyl)propan-2-yl)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.