SPL Set ID: 9405556c-20e0-4e47-b1b0-7872bcc6517e

Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 10 mg per 5 mL (2 mg/mL) : Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). 100 mg per 5 mL (20 mg/mL) : Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine). The chemical name is 7,8-didehydro-4,5 alpha- epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C 17 H 21 NO 3 ) 2 •H 2 SO 4 •5H 2 O, and it has the following chemical structure. Morphine sulfate, USP is a white to off-white crystalline powder or a fine white to light yellow powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pK a is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). For the 10 mg per 5 mL (2 mg/mL) concentration: Each 5 mL of oral solution contains 10 mg of morphine sulfate, USP and the following inactive ingredients: citric acid anhydrous, disodium edetate, FD&C Green No. 3, glycerin, sodium benzoate, sorbitol solution, and purified water. May contain sodium citrate dihydrate for pH adjustment. For the 100 mg per 5 mL (20 mg/mL) concentration (only for opioid tolerant adults) : Each 5 mL of oral solution contains 100 mg of morphine sulfate, USP and the following inactive ingredients: citric acid, edetate disodium, glycerin, sodium benzoate, sorbitol solution, and purified water. May contain sodium citrate for pH adjustment. Chemical Structure