Granisetron Hydrochloride Compounded Oral Suspension

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Granisetron Hydrochloride Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of granisetron (C₁₈H₂₄N₄O). Prepare Granisetron Hydrochloride Compounded Oral Suspension containing 0.05 mg/mL of granisetron as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉).

Calculate the required quantity of each ingredient for the total amount to be prepared. If using tablets, place the required number of tablets in a suitable mortar, and comminute the tablets to a ne powder with a pestle, or add Granisetron Hydrochloride powder. Add the Vehicle in small portions, and triturate to make a smooth paste. Add increasing volumes of the Vehicle to make a Granisetron Hydrochloride suspension that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough Vehicle to bring to nal volume, and mix well.

2 ASSAY

Procedure

Mobile phase: Acetonitrile and 50 mM monobasic sodium dihydrogen phosphate (3:17). Adjust with phosphoric acid to a pH of 7.0. Make adjustments if necessary (see Chromatography 〈621〉, System Suitability).

Standard stock solution: 1.0 mg/mL of USP Granisetron Hydrochloride RS

Standard solution: Transfer 2.5 mL of Standard stock solution to a 100-mL volumetric ask, and dilute with Mobile phase to volume to obtain a solution containing 25 µg/mL of granisetron hydrochloride.

Sample solution: Shake the Oral Suspension thoroughly by hand. Pipet 5.0 mL into a 10-mL volumetric ask. Dilute with Mobile phase to volume, and mix.

2.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 300 nm

Column: 4.6-mm × 15-cm; 5-µm packing L10

Flow rate: 1.0 mL/min

Injection volume: 20 µL

2.2 System suitability

Sample: Standard solution

[Note—The retention time of the granisetron peak is 7.0 min.]

Suitability requirements

Relative standard deviation: NMT 2.0% for the replicate injections

2.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of granisetron (C₁₈H₂₄N₄O) in the volume of Oral Suspension taken: 

Result = (r_U /r_S ) × (C_S /C_U) × (M_r1 /M_r2 ) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Granisetron Hydrochloride RS in the Standard solution (µg/mL)

C_U = nominal concentration of granisetron in the Sample solution (µg/mL)

M_r1 = molecular weight of granisetron, 312.41

M_r2 = molecular weight of granisetron hydrochloride, 348.87

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 4.0–4.5

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 when stored 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 Granisetron Hydrochloride RS