Morphine Sulfate Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Morphine Sulfate Injection is a sterile solution of Morphine Sulfate in Water for Injection. It contains NLT 90.0% and NMT 110.0% 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.
2 IDENTIFICATION
A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
B. IDENTIFICATION TESTS (191)-GENERAL, Sulfate: It meets the requirements of test A.
3 ASSAY
PROCEDURE
Mobile phase: Dissolve 0.73 g of sodium 1-heptanesulfonate in 720 mL of water, and add 280 mL of methanol and 10 mL of glacial acetic acid.
System suitability solution: 0.24 mg/mL of USP Morphine Sulfate RS and 0.15 mg/mL of phenol in Mobile phase
Standard solution: 0.24 mg/mL of USP Morphine Sulfate RS (on the anhydrous basis) in Mobile phase. [NOTE-Prepare a fresh solution daily.]
Sample solution: Nominally 0.24 mg/mL of morphine sulfate from the Injection in Mobile phase
Chromatographic system
(See Chromatography (621), System Suitability.)
Mode: LC
Detector: UV 284 nm
Column: 3.9-mm x 30-cm; packing L1
Flow rate: 1.5 mL/min
Injection volume: 25 µL
System suitability
Samples: System suitability solution and Standard solution
[NOTE-The relative retention times for phenol and morphine are about 0.7 and 1.0, respectively.]
Suitability requirements
Resolution: NLT 2.0 between phenol and morphine sulfate, System suitability solution
Tailing factor: NMT 2.0 for the morphine sulfate peak, System suitability solution
Relative standard deviation: NMT 2.0%, Standard solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of morphine sulfate pentahydrate [(C17H19NO3)2 · H2SO4 · 5H2O] in each mL of the Injection taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) ×100
rU = peak response from the Sample solution
rS = peak response from the Standard solution
CS = concentration of USP Morphine Sulfate RS in the Standard solution (mg/mL)
CU = nominal concentration of the Sample solution (mg/mL)
Mr1 = molecular weight of morphine sulfate pentahydrate, 758.83
Mr2 = molecular weight of anhydrous morphine sulfate, 668.77
Acceptance criteria: 90.0%-110.0%
4 SPECIFIC TESTS
PH (791): 2.5-6.5
BACTERIAL ENDOTOXINS TEST (85): It contains NMT 17.0 USP Endotoxin Units/mg of morphine sulfate. If labeled for intrathecal use, it contains NMT 14.29 USP Endotoxin Units/mg of morphine sulfate.
PARTICULATE MATTER IN INJECTIONS (788): Meets the requirements under small-volume injections
OTHER REQUIREMENTS: It meets the requirements under Injections and Implanted Drug Products (1).
5 ADDITIONAL REQUIREMENTS
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 (7), Labels and Labeling for Injectable Products. 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.
USP REFERENCE STANDARDS (11)
USP Morphine Sulfate RS
