morphine sulfate injection, USP 50 MG/ML VIAL Description
11 DESCRIPTION
Morphine, an opioid agonist, is isolated in the form of sulfate salt and pentahydrate, which has the chemical name as 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2:1) (salt), pentahydrate. It has a molecular weight of 758.83 and a chemical formula of (C17H19NO3)2 ∙ H2SO4 ∙ 5H2O, with the following structural formula:
Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. When exposed to air, it gradually loses water of hydration, and darkens on prolonged exposure to light. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4).
Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives, to be administered by the intravenous route. It is available in 1,000 mg/20 mL (50 mg/mL) and 2,500 mg/50 mL (50 mg/mL) single-dose flip top vials for the preparation of large volume parenteral solutions.
Each milliliter of sterile solution contains 50 mg Morphine Sulfate, USP (Pentahydrate) and the following inactive ingredients: 0.2 mg edetate disodium, 0.8 mg citric acid, sodium chloride to adjust isotonicity, and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0.
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Description
11 DESCRIPTION
Morphine, an opioid agonist, is isolated in the form of sulfate salt and pentahydrate, which has the chemical name as 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2:1) (salt), pentahydrate. It has a molecular weight of 758.83 and a chemical formula of (C17H19NO3)2 ∙ H2SO4 ∙ 5H2O, with the following structural formula:
Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. When exposed to air, it gradually loses water of hydration, and darkens on prolonged exposure to light. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4).
Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives, to be administered by the intravenous route. It is available in 1,000 mg/20 mL (50 mg/mL) and 2,500 mg/50 mL (50 mg/mL) single-dose flip top vials for the preparation of large volume parenteral solutions.
Each milliliter of sterile solution contains 50 mg Morphine Sulfate, USP (Pentahydrate) and the following inactive ingredients: 0.2 mg edetate disodium, 0.8 mg citric acid, sodium chloride to adjust isotonicity, and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0.
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