Enalapril EP Impurity A (Crude) is a process-related byproduct derived from the synthetic pathway of Enalapril, featuring a substituted tetrazole ring conjugated to a partially oxidized pentanoic acid chain. Its structure retains the core scaffold of Enalapril but incorporates an additional hydroxyl group at the ฮณ-position of the carboxylic acid, resulting from incomplete esterification during API synthesis. This impurity serves as a critical HPLC reference standard for quantifying residual byproducts in Enalapril drug substance batches.
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InChI=1S/C20H28N2O5/c1-3-27-20(26)16(12-11-15-8-5-4-6-9-15)21-14(2)18(23)22-13-7-10-17(22)19(24)25/h4-6,8-9,14,16-17,21H,3,7,10-13H2,1-2H3,(H,24,25)/t14-,16+,17-/m0/s1
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