Berberine Impurity 8 (CAS 1888416-22-5) is a characterized process-related impurity with molecular formula C18H23NO4 and monoisotopic mass approximately 317.163 Da, represented by InChI=1S/C18H23NO4/c1-21-16-8-7-13(11-17(16)22-2)9-10-19-12-14-5-4-6-15(20)18(14)23-3/h4-8,11,19-20H,9-10,12H2,1-3H3. The substance contains an isoquinoline-derived alkaloid scaffold bearing one nitrogen and multiple oxygenated substituents, which influences polarity and chromatographic behavior. Routine characterization and control employ HPLC with UV/DAD and LC-MS for quantitation and profiling, supported by 1H/13C NMR for structural confirmation. Quality management focuses on specification limits, stability assessment, and trace-level monitoring to maintain berberine API impurity profiles.
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