Ganciclovir
(gan sye' kloe vir).
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 [82410-32-0]. DEFINITION
Ganciclovir contains NLT 98.0% and NMT 102.0% of C9H13N5O4, calculated on the anhydrous basis.
IDENTIFICATION
• B. Ultraviolet Absorption 197U
Sample solution:
10 µg/mL in methanol
ASSAY
• 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. [NoteSonicate 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
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4.6-mm × 25-cm; packing L9
Column temperature:
40
Flow rate:
1.5 mL/min
Injection size:
20 µL
System suitability
Sample:
System suitability solution
[NoteThe 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%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C9H13N5O4 in the portion of Ganciclovir taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria:
98.0%102.0% on the anhydrous basis
IMPURITIES
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 = (rU/rT) × 100
Acceptance criteria
Ganciclovir related compound A:
NMT 0.5%
Total impurities:
NMT 1.5%
SPECIFIC TESTS
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers. Store at 25, excursions permitted between 15 and 30.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 3317
Pharmacopeial Forum: Volume No. 36(4) Page 923
|