Ganciclovir 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

Ganciclovir Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of ganciclovir (C₉H₁₃N₅O₄).

Prepare Ganciclovir Compounded Oral Suspension 100 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

Add sufficient Vehicle for Oral Solution to wet the Ganciclovir powder, and triturate to form a smooth paste. Add additional Vehicle for Oral Solution to about half the final volume, and transfer the contents of the mortar to a calibrated bottle. Using additional Vehicle for Oral Solution, rinse the mortar, and transfer the contents, stepwise and quantitatively, to bring to final volume. Mix well.

[CAUTION-Avoid skin contact or inhalation of ganciclovir by using protective gloves and a fume hood or surgical mask.]

2 ASSAY

2.1 PROCEDURE

Solution A: 25-mM monobasic sodium phosphate solution. Adjust with phosphoric acid to a pH of 2.5.

Mobile phase: Acetonitrile and Solution A (2.5:97.5). Filter and degas.

Internal standard solution: 0.4 mg/mL of hypoxanthine

Standard stock solution: 1.0 mg/mL of USP Ganciclovir RS

Standard solution: 6 µg/mL of ganciclovir and 4 µg/mL of hypoxanthine prepared from Standard stock solution and Internal standard solution

Sample solution: Transfer about 1 mL of Oral Suspension from each bottle to a plastic weighing cup, and weigh to determine density. [NOTE-The exact volume of Oral Suspension taken from each bottle is calculated by the suspension density.] Transfer the Oral Suspension to a 100-mL volumetric flask, and add 50 mL of water. Place the volumetric flask on a mechanical shaker for 30 min, and dilute with water to volume. Transfer 0.6 mL of this solution and 1 mL of the Internal standard solution to a 100-mL volumetric flask, and dilute with water to volume to obtain a solution with a nominal concentration of 6 µg/mL of ganciclovir and 4 µg/mL of hypoxanthine.

2.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm x 10-cm; 5-µm packing L1

Flow rate: 1.5 mL/min

Injection volume: 10 µL

2.3 System suitability

Sample: Standard solution

[NOTE-The relative retention times for hypoxanthine and ganciclovir are 0.75 and 1.0, respectively.]

Suitability requirements

Relative standard deviation: NMT 1.5% for replicate injections

2.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of ganciclovir (C₉H₁₃N₅O₄) in the portion of Oral Suspension taken:

Result = (R_U/R_S) x (C_S/C_U) x 100

R_U = peak response ratio of ganciclovir to the internal standard from the Sample solution

R_S = peak response ratio of ganciclovir to the internal standard from the Standard solution

C_S = concentration of USP Ganciclovir RS in the Standard solution (mg/mL)

C_U = nominal concentration of ganciclovir in the Sample solution (mg/mL)

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 4.0-5.0

4 ADDITIONAL REQUIREMENTS

4.1 PACKAGING AND STORAGE

Package in tight, light-resistant containers. Store at controlled room temperature.

4.2 BEYOND-USE DATE

NMT 90 days after the date on which it was compounded when stored at controlled room temperature

4.3 LABELING

Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.

4.4 USP REFERENCE STANDARDS (11)

USP Ganciclovir RS