Product Details

4-(4-Aminophenyl)morpholin-3-one (CAS 438056-69-0) is a primary aromatic amine morpholinone of the aminophenyl morpholin-3-one chemical class. This compound is an important part of making Rivaroxaban, a direct Factor Xa inhibitor, and Linezolid-class oxazolidinone antibiotics. It might also show up as a metabolic breakdown product or an impurity related to the process in Rivaroxaban. The primary aromatic amine (NH2) has an ICH M7 mutagenic structural alert (Ames-positive risk). If it is still in APIs above the TTC limit (≤1.5 µg/day), a full genotoxicity assessment and ICH M7 risk mitigation are needed. 

ApiSyn offers 4-(4-Aminophenyl)morpholin-3-one (CAS 438056-69-0) as a certified pharmaceutical impurity reference standard and synthetic intermediate for Rivaroxaban ICH M7 mutagenic impurity evaluation, method validation, and quality control.