Ethyl dapagliflozin impurity arises from incomplete esterification or side reactions during synthesis. Comprehensive analytical characterization using HPLC with MS detection and 1H and 13C NMR confirms structure, retention behavior and mass profile. This process-related impurity impacts assay and impurity profiles and may affect stability and safety if above specification. Control strategies include optimized reaction parameters, purification by preparative HPLC, crystallization, and validated cleaning procedures. Identification and qualification follow ICH Q3A and Q3B thresholds with targeted LC-MS/MS methods for trace quantitation and forced degradation studies to assess degradants. Robust quality control limits and batch release testing ensure regulatory compliance and product quality.
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