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Acyclovir
C8H11N5O3 225.20
6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-.
9-[(2-Hydroxyethoxy)methyl]guanine [59277-89-3].
» Acyclovir contains not less than 98.0 percent and not more than 101.0
percent of C8H11N5O3, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight containers. Store at room temperature. Protect
from light and moisture.
Identification—
B: The retention time of the major peak in the chromatogram of the Assay preparation
corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay
and limit for guanine.
Visualization: 1.
Limit: 1%.
Organic volatile impurities, Method V 467 : meets the requirements.
Mobile phase— Prepare a filtered and degassed solution of glacial acetic acid in water (1 in
1000). Make adjustments if necessary (see System Suitability under Chromatography 621
).
System suitability solution 1— Dissolve accurately weighed quantities of USP Acyclovir RS and
guanine in 0.1 N sodium hydroxide, and dilute quantitatively, and stepwise if necessary, with
water to obtain a solution having known concentrations of about 0.1 mg of each per mL.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation, the
Guanine standard preparation, and the Assay preparation into the chromatograph, record the
chromatograms, and measure the responses for all the peaks. Calculate the quantity, in µg, of
guanine in the portion of Acyclovir taken by the formula:
1000C(r / r )
U S
in which C is the concentration, in µg per mL, of guanine in the Guanine standard preparation;
and r and r are the peak responses due to guanine in the Assay preparation and the Guanine
U S
standard preparation, respectively: not more than 0.7% of guanine is found. Calculate the
quantity, in mg, of C8H11N5O3 in the portion of Acyclovir taken by the formula:
1000C(r / r )
U S
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP30–NF25 Page 1300
Pharmacopeial Forum : Volume No. 30(5) Page 1580
Phone Number : 1-301-816-8394