Quinidine Sulfate Compounded Oral Suspension
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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
Quinidine Sulfate Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of quinidine sulfate [(C20H24N2O2)2 · H2SO4 · 2H2O]. Prepare Quinidine Sulfate Compounded Oral Suspension 10 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).
| Quinidine Sulfate | 1 g |
| Vehicle: a 1:1 mixture of Vehicle for Oral Solution (regular or sugar-free), NF, and Vehicle for Oral Suspension, NF, a sufficient quantity to make | 100 mL |
If using Quinidine Sulfate tablets, place in a suitable mortar, and comminute into a fine powder, or add Quinidine Sulfate powder to the mortar. Add 15 mL of the Vehicle, and mix to a uniform paste. Add the Vehicle in small portions almost to volume, and mix thoroughly after each addition. Transfer the contents of the mortar to the calibrated bottle. Add sufficient Vehicle to volume, and mix well.
2 ASSAY
2.1 Procedure
Solution A: Add 35.0 mL of methanesulfonic acid to 20.0 mL of glacial acetic acid, and dilute with water to 500 mL.
Solution B: Dissolve 10.0 mL of diethylamine in water to obtain 100 mL of solution.
Mobile phase: Acetonitrile, Solution A, Solution B, and water (10:1:1:40)
Standard solution: 100 µg/mL of USP Quinidine Sulfate RS in Mobile phase
Sample solution: Agitate the container of Oral Suspension for 30 min on a rotating mixer, remove a 5-mL sample, and store in a clear glass vial at −70° until analyzed. At the time of analysis, remove the sample from the freezer, allow it to reach room temperature, and mix on a vortex mixer for 30 s. Pipet 1.0 mL of the Sample solution into a 100-mL volumetric flask, and dilute with Mobile phase to volume.
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
Detector: UV 235 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection volume: 20 µL
System suitability
Sample: Standard solution
[Note—The retention time for quinidine sulfate is about 8.5 min.]
Suitability requirements
Relative standard deviation: NMT 1.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of quinidine sulfate[(C20H24N2O2)2 · H2SO4 · 2H2O] in the portion of Oral Suspension taken:
Result = [(rB,D + rD,U)/(rB,S + rD,S)] × (CS/V) × 100
rB,D = peak response of quinidine from the Sample solution
rD,U = peak response of dihydroquinidine from the Sample solution
rB,S = peak response of quinidine from the Standard solution
rD,S = peak response of dihydroquinidine from the Standard solution
CS = concentration of USP Quinidine Sulfate RS in the Standard solution (mg/mL)
V = volume of Oral Suspension taken (mL)
Acceptance criteria: 90.0%–110.0%
3 SPECIFIC TESTS
pH 〈791〉: 3.4–4.4
4 ADDITIONAL REQUIREMENTS
Packaging and Storage: Package in tight, light-resistant containers. Store at room temperature, or in a refrigerator.
Beyond-Use Date: NMT 60 days after the date on which it was compounded when stored at room temperature, or in a refrigerator
Labeling: Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.
USP Reference Standards 〈11〉
USP Quinidine Sulfate RS
