It is used exclusively as a highly characterized reference standard in pharmaceutical analysis for method development validation and quality control during sildenafil API and drug product manufacturing.

Its purpose is to enable sensitive detection and accurate quantification of trace nitrosamine impurities in sildenafil products to ensure compliance with stringent FDA EMA USP and other regulatory safety limits.

N-Nitroso sildenafil is an N-nitroso impurity formed from the secondary amine in sildenafil characterized chemically as a nitrosamine derivative with molecular formula CHNOS.