Dolasetron Mesylate 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
Dolasetron Mesylate Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of dolasetron mesylate (C19H20N2O3 · CH4O3S).
Prepare Dolasetron Mesylate Compounded Oral Suspension 10 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).
| Dolasetron Mesylate | 1 g |
| Vehicle: a 1:1 mixture of Vehicle for Oral Solution (regular or sugarfree), NF, and Vehicle for Oral Suspension, NF, a sucient quantity to make | 100 mL |
If using tablets, place the required number in a suitable mortar, and comminute to a fine powder, or add Dolasetron Mesylate powder to the mortar. Add 20 mL of Vehicle, and mix to a uniform paste. Add the Vehicle in small portions, and mix well after each addition. Transfer, stepwise and quantitatively, to a calibrated bottle. Add the Vehicle in portions to rinse the mortar, add sufficient Vehicle to bring to final volurne, and mix well.
2 ASSAY
PROCEDURE
Solution A: 0.05 M ammonium acetate adjusted with diluted ammonium hydroxide to a pH of 7.5
Mobile phase: Acetonitrile and Solution A (24:76). Filter and degas.
Diluent: Acetonitrile and water (24:76)
Standard stock solution: 500 µg/mL of USP Dolasetron Mesylate RS in Diluent
Standard solution: 10 µg/mL of USP Dolasetron Mesylate RS prepared from the Standard stock solution in Mobile phase
Sample solution: 10 µg/mL of dolasetron mesylate prepared from Oral Suspension and Diluent. Shake each sample thoroughly by hand for 15 s, centrifuge at 1000 rpm for 2 min, and use the supernatant.
Chromatographic system
(See Chromatography (621), System Suitability.)
Mode: LC
Detector: UV 280 nm
Column: 4.6-mm x 15-cm; 5-µm packing L10
Column temperature: 30°
Flow rate: 0.8 mL/min
Injection volume: 5 µL
System suitability
Sample: Standard solution
[NOTE-The retention time for dolasetron mesylate is about 6.9 min.]
Suitability requirements
Relative standard deviation: NMT 1.4% for replicate injections
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of dolasetron mesylate (C19H20N2O3 · CH4O3S) in the portion of Oral Suspension taken:
Result = (ru /rs ) × (Cs /Cu ) × 100
ru = peak response from the Sample solution
rs = peak response from the Standard solution
Cs = concentration of USP Dolasetron Mesylate RS in the Standard solution (µg/mL)
Cu = nominal concentration of dolasetron mesylate in the Sample solution (µg/mL)
Acceptance criteria: 90.0%–110.0%
3 SPECIFIC TESTS
PH (791): 3.6-4.6
4 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store at controlled room temperature, or in a refrigerator.
BEYOND-USE DATE: NMT 90 days after the date on which it was compounded when stored at controlled 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 Dolasetron Mesylate RS
