SPL Set ID: 9f6e4e57-a489-4b36-b093-b93865d3717c

Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril is a synthetic peptide derivative that is manufactured as a dihydrate and is chemically described as 1-[ N 2 -[( S )-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate. Its molecular formula is C 21 H 31 N 3 O 5 ·2H 2 O and its structural formula is: Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52 (for dihydrate). It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. QBRELIS (lisinopril), 1 mg/mL, is a ready-to-use aqueous formulation. Each 1 mL of the oral solution contains 1.09 mg of lisinopril dihydrate, which is equivalent to 1 mg of lisinopril as the active ingredient and the following inactive ingredients: purified water, xylitol, sodium citrate, citric acid, sodium benzoate, and either hydrochloric acid or sodium hydroxide which may be added for pH adjustment. The solution is clear to slightly opalescent. The pH of the solution ranges from 4.3 to 5.1. QBRELIS is supplied as 150 mL of the solution packaged in a 150-mL round, white, opaque, high-density polyethylene (HDPE) bottle with a white, polypropylene, child-resistant closure with a heat induction layered inner seal. Structural Formula