Atorvastatin EP Impurity F, also described as Atorvastatin amide acid, di-amide acid, or diamino impurity free base, is a process- and degradation-related related substance associated with atorvastatin synthesis and amide coupling side reactions. It corresponds to CAS 887196-24-9, molecular formula C40H48FN3O8, and molecular weight 717.84 g/mol. The structure reflects over-activation or hydrolytic rearrangement of the side-chain amide functionality rather than a classical mutagenic alerting group. Characterization typically requires LC-MS/MS, high-resolution MS, and orthogonal HPLC-UV or LC-ELSD methods, with NMR confirmation when isolated. Its presence is evaluated within impurity profiling and specification setting under pharmacopeial and ICH quality frameworks.
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