Lisinopril is a drug of the angiotensin-converting enzyme (ACE) inhibitor class that is primarily used in the treatment of hypertension. During the scale-up of the lisinopril process, one unknown impurity was observed and is identified. The present work describes the origin, synthesis, characterization, and control of this impurity. This paper also describes the synthesis and characterization of three other impurities listed in the European Pharmacopoeia 8.4 (Impurity C, D, and F).

This study identifies and synthesizes an unknown impurity in lisinopril production, as well as three other European Pharmacopoeia 8.4 impurities, to improve lisinopril quality and control.

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Synthesis and Characterization of Compounds Related to Lisinopril

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