Printed on: Thu Feb 09 2023, 12:15:26 AM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-1ECE9138-6D88-414B-B17A-ECEE155F7506_1_en-US

Printed by: Dang Van Vu Official Date: Official Prior to 2013 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: uh823 DOI: https://doi.org/10.31003/USPNF_M893_01_01
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rU = peak response of the Sample solution

Acyclovir Capsules rS = peak response of the Standard solution
DEFINITION CS = concentration of USP Acyclovir RS in the Standard
Acyclovir Capsules contain NLT 93.0% and NMT 107.0% of solution (mg/mL)
the labeled amount of acyclovir (C8H11N5O3). CU = nominal concentration of acyclovir in the Sample
solution (mg/mL)
IDENTIFICATION
• A. The retention time of the major peak of the Sample Acceptance criteria: 93.0%–107.0%
solution corresponds to that of the Standard solution, as
obtained in the Assay. PERFORMANCE TESTS
• DISSOLUTION á711ñ
ASSAY Medium: 0.1 N hydrochloric acid; 900 mL
• PROCEDURE Apparatus 1: 100 rpm
Mobile phase: 0.02 M acetic acid Time: 45 min
System suitability solution A: 0.1 mg/mL each of USP Detector: UV 254 nm
Acyclovir RS and guanine. Dissolve in 0.1 N sodium Standard solution: USP Acyclovir RS in Medium
hydroxide, and dilute with water. Sample solutions: Dilute with Medium to a concentration
System suitability solution B: 2.0 µg/mL of guanine. that is similar to the Standard solution.
Dissolve in 0.1 N sodium hydroxide, and dilute with water. Analysis: Determine the amount of acyclovir (C8H11N5O3)
Standard solution: 0.1 mg/mL of USP Acyclovir RS. Dissolve dissolved from UV absorption at the wavelength of
in 0.1 N sodium hydroxide, and dilute with water. maximum absorption on filtered portions of the solution
Sample solution: Nominally 0.1 mg/mL of acyclovir under test.
prepared as follows. Transfer the contents of Capsules Tolerances: NLT 75% (Q) of the labeled amount of acyclovir

al
equivalent to 10 mg of acyclovir (NLT 10 Capsules) to a (C8H11N5O3) is dissolved.
100-mL volumetric flask. Dissolve in 10 mL of 0.1 N sodium • UNIFORMITY OF DOSAGE UNITS á905ñ: Meet the
hydroxide, dilute to volume with water, and filter. requirements for Content Uniformity
Chromatographic system
(See Chromatography á621ñ, System Suitability.)
ci IMPURITIES
Mode: LC • PROCEDURE
Detector: UV 254 nm Mobile phase, System suitability solution A, System
Column: 4.2-mm × 25-cm; packing L1 suitability solution B, Sample solution,
Flow rate: 1.5 mL/min Chromatographic system, and System suitability:
Injection volume: 20 µL Proceed as directed in the Assay.
Analysis: Sample solution
ffi
System suitability
Samples: System suitability solution A and System suitability Calculate the percentage of each impurity in the portion of
solution B Capsules taken:
[NOTE—The relative retention times for guanine and
acyclovir are about 0.6 and 1.0, respectively, in Result = (rU/rT) × 100
System suitability solution A.]
rU = peak response for each impurity
O

Suitability requirements
Resolution: NLT 2.0 between guanine and acyclovir, rT = sum of the responses for all of the peaks
System suitability solution A
Relative standard deviation: NMT 2.0% for the Acceptance criteria
acyclovir peak, System suitability solution A Guanine: NMT 2.0%
Relative standard deviation: NMT 2.0%, System Any individual impurity: NMT 0.5%
suitability solution B ADDITIONAL REQUIREMENTS
Analysis: Standard solution and Sample solution • PACKAGING AND STORAGE: Preserve in tight containers.
Calculate the percentage of the labeled amount of acyclovir Store between 15° and 25°. Protect from light and
(C8H11N5O3) in the portion of Capsules taken: moisture.
• USP REFERENCE STANDARDS á11ñ
Result = (rU/rS) × (CS/CU) × 100 USP Acyclovir RS

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