Ganciclovir

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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C₉H₁₃N₅O₄ 255.23

6H-Purin-6-one, 2-amino-1,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-;

9-[[2-Hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine CAS RN^®: 82410-32-0; UNII: P9G3CKZ4P5.

1 DEFINITION

Ganciclovir contains NLT 98.0% and NMT 102.0% of C₉H₁₃N₅O₄, calculated on the anhydrous basis.

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K (CN 1-MAY-2020)

Change to read:

B. SPECTROSCOPIC IDENTIFICATION TESTS (197), Ultraviolet-Visible Spectroscopy: 197U (CN 1-MAY-2020)

Sample solution: 10 µg/mL in methanol

3 ASSAY

3.1 PROCEDURE

Solution A: Trifluoroacetic acid and water (0.5 in 1000)

Mobile phase: Acetonitrile and Solution A (1:1)

System suitability solution: 0.1 mg/mL each of USP Ganciclovir RS and USP Ganciclovir Related Compound A RS in Mobile phase. [NOTE-Sonicate the solution if necessary.]

Standard solution: 0.22 mg/mL of USP Ganciclovir RS in Mobile phase

Sample solution: 0.22 mg/mL of Ganciclovir in Mobile phase

3.2 Chromatographic system

(See Chromatography

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm x 25-cm; packing L9

Column temperature: 40°

Flow rate: 1.5 mL/min

Injection size: 20 µL

3.3 System suitability

Sample: System suitability solution

[NOTE-The relative retention times for ganciclovir related compound A and ganciclovir are 0.9 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 1.4 between ganciclovir and ganciclovir related compound A

Column efficiency: NLT 5000 theoretical plates

Tailing factor: NMT 1.4

Relative standard deviation: NMT 1.0%

3.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of C₉H₁₃N₅O₄ in the portion of Ganciclovir taken:

Result = (r_U/r_S) x (C_S/C_U) x 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

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

Acceptance criteria: 98.0%-102.0% on the anhydrous basis

4 IMPURITIES

4.1 INORGANIC IMPURITIES

RESIDUE ON IGNITION (281): NMT 0.1%

4.2 ORGANIC IMPURITIES

PROCEDURE

Solution A, Mobile phase, System suitability solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Sample solution: 0.22 mg/mL of Ganciclovir in Mobile phase

Analysis

Sample: Sample solution

Calculate the percentage of each impurity in the portion of Ganciclovir taken:

Result = (r_U/r_T) × 100

r_U = peak response for each impurity in the Sample solution

r_T = sum of the responses of all the peaks

Acceptance criteria

Ganciclovir related compound A: NMT 0.5%

Total impurities: NMT 1.5%

5 SPECIFIC TESTS

WATER DETERMINATION, Method I(921): NMT 6.0%

[NOTE-Ganciclovir is extremely hygroscopic.]

6 ADDITIONAL REQUIREMENTS

6.1 PACKAGING AND STORAGE

Preserve in well-closed containers. Store at 25°, excursions permitted between 15° and 30°.

6.2 USP REFERENCE STANDARDS (11)

USP Ganciclovir RS

USP Ganciclovir Related Compound A RS