11 DESCRIPTION
Preservative-free morphine sulfate injection (morphine sulfate injection) is an opioid agonist, available as a sterile, nonpyrogenic isobaric solution of morphine sulfate in strengths of 0.5 mg or 1 mg morphine sulfate per mL, free of antioxidants, preservatives or other potentially neurotoxic additives, and is intended for intravenous, epidural, or intrathecal administration. Morphine is the most important alkaloid of opium and is a phenanthrene derivative. It is available as the sulfate salt, chemically identified as 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2:1) (salt), pentahydrate, with the following structural formula:
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| (C17H19NO3)2 ∙ H2SO4 ∙ 5H2O | Molecular Weight is 758.83 | |
Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. 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).
Each mL of preservative-free morphine sulfate injection contains morphine sulfate, USP 0.5 mg (5 mg/10 mL) or 1 mg (10 mg/ 10 mL) and sodium chloride 9 mg in Water for Injection. The pH range is 2.5 – 6.5. Contains no preservative. Each 10 mL container of preservative-free morphine sulfate injection is intended for SINGLE DOSE ONLY.