U.S. PHARMACOPEIA

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Morphine Sulfate Injection
» Morphine Sulfate Injection is a sterile solution of Morphine Sulfate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of morphine sulfate pentahydrate [(C17H19NO3)2·H2SO4·5H2O]. Injection intended for intramuscular or intravenous administration may contain sodium chloride as a tonicity-adjusting agent, and suitable antioxidants and antimicrobial agents. Injection intended for intrathecal or epidural use may contain sodium chloride as a tonicity-adjusting agent, but contains no other added substances.
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light. Preserve Injection labeled “Preservative-free” in single-dose containers.
Labeling— It meets the requirements for Labeling under Injections 1. Label it also to state that the Injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. Injection containing no antioxidant or antimicrobial agents prominently bears on its label the words “Preservative-free,” and includes, in its labeling, its routes of administration and the statement that it is not to be heat-sterilized. Injection containing antioxidant or antimicrobial agents includes in its labeling its routes of administration and the statement that it is not for intrathecal or epidural use.
Identification—
A: Dilute with methanol, if necessary, a volume of Injection to obtain a solution containing 500 µg per mL. Apply 20 µL of this solution and 20 µL of a solution of USP Morphine Sulfate RS in a mixture of methanol and water (1:1) containing 500 µg per mL to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 250-µm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of acetone, methanol, and ammonium hydroxide (50:50:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, and allow the solvent to evaporate. Locate the spots on the plate by examination under short-wavelength UV light: the RF value of the principal spot obtained from the Injection corresponds to that obtained from the Standard solution.
B: It responds to the barium chloride test for Sulfate 191.
Bacterial endotoxins 85— It contains not more than 17.0 USP Endotoxin Units per mg of morphine sulfate; if labeled for intrathecal use, it contains not more than 14.29 USP Endotoxin Units per mg of morphine sulfate.
pH 791: between 2.5 and 6.5.
Particulate matter 788— meets the requirements under small-volume Injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase , Standard preparation, System suitability preparation, and Chromatographic system—Prepare as directed in the Assay under Morphine Sulfate.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 24 mg of morphine sulfate, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Morphine Sulfate. Calculate the quantity, in mg, of morphine sulfate pentahydrate [(C17H19NO3)2·H2SO4·5H2O] in each mL of the Injection taken by the formula:
(758.85 / 668.77)(100C / V)(rU / rS),
in which 758.85 and 668.77 are the molecular weights of morphine sulfate pentahydrate and anhydrous morphine sulfate, respectively, V is the volume, in mL, of Injection taken, and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 1460
Phone Number : 1-301-816-8139