Abacavir Oral Solution

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

Abacavir Oral Solution contains NLT 90.0% and NMT 110.0% of the labeled amount of abacavir (C₁₄H₁₈N₆O).

2 IDENTIFICATION

The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 PROCEDURE

Solution A: Trifluoroacetic acid and water (0.05:99.95)

Solution B: Methanol and water (17:3)

Diluent: 1 mL of phosphoric acid diluted with water to 1000 mL

Mobile phase: See the gradient table below.

System suitability solution: 0.2 mg/mL of USP Abacavir System Suitability Mixture RS in Diluent

Standard solution: 0.46 mg/mL of USP Abacavir Sulfate RS in Diluent

Sample solution: Equivalent to 0.4 mg/mL of abacavir in Diluent, from Oral Solution. [NOTE-Sonicate, if necessary.]

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm x 15-cm; 5-µm packing 11

Column temperature: 30"

Flow rate: 0.8 mL/min

Injection size: 10 µL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 1.5 between abacavir and trans-abacavir, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of abacavir (C₁₄H₁₈N₆O) in the portion of Oral Solution taken:

Result = (r_u/r_s) x (C_s/C_u) × (M_r1/M_r2) × 100

r_u = peak area of abacavir from the Sample solution

r_s = peak area of abacavir from the Standard solution

C_s = concentration of USP Abacavir Sulfate RS in the Standard solution (mg/mL)

C_u = nominal concentration of abacavir in the Sample solution (mg/mL)

M_r1 = molecular weight of abacavir mutiplied by 2, 572.66

M_r2 = molecular weight of abacavir sulfate, 670.74 2

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

DELIVERABLE VOLUME (698): Meets the requirements

5 IMPURITIES

5.1 ORGANIC IMPURITIES

5.1.1 PROCEDURE

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

Sensitivity solution: 0.2 µg/mL of USP Abacavir Sulfate RS in Diluent, from the Standard solution. [NOTE-The concentration of this solution is 0.05% of the nominal concentration of the Sample solution.]

5.1.1.1 Analysis

Samples: Diluent, Standard solution, Sample solution, and Sensitivity solution. [NOTE-In the Sample solution disregard any peaks corresponding to peaks identified in the Diluent and any peak with a peak area less than the abacavir peak area in the Sensitivity solution.]

Calculate the percentage of each impurity in the portion of Oral Solution taken:

Result = (r_u/r_s) x (C_s/C_u) × (1/F) × (M_r1/M_r2) × 100

r_u = peak area of abacavir from the Sample solution

r_s = peak area of abacavir from the Standard solution S

C_s = concentration of USP Abacavir Sulfate RS in the Standard solution (mg/mL)

C_u = nominal concentration of abacavir in the Sample solution (mg/mL)

F = relative response factor for each impurity from Impurity Table 1.

M_r1 = molecular weight of abacavir mutiplied by 2, 572.66

M_r2 = molecular weight of abacavir sulfate, 670.74 12

5.1.1.2 Acceptance criteria

Individual impurities: See Impurity Table 1.

Total impurities: NMT 2.0%

a N⁶-Cyclopropyl-9H-purine-2,6-diamine.

b [(1S,4R)-4-(2,6-Diamino-9H-purin-9-yl)cyclopent-2-enyl]methanol.

c {(1R,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-cyclopent-2-enyl}methanol. It is a process impurity and monitored in the drug substance.

6 SPECIFIC TESTS

6.1 MICROBIAL ENUMERATION TESTS (61) and TESTS FOR SPECIFIED MICROORGANISMS (62):

The total aerobic microbial count does not exceed 100 cfu/mL, and the total combined molds and yeast count does not exceed 10 cfu/ml. It also meets the requirement for absence of Escherichia coli.

Change to read:

6.2 PH (791):

3.8-4.8 (RB 1-Mar-2022)

7 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in well-closed containers. Store at controlled room temperature.

USP REFERENCE STANDARDS (11)

USP Abacavir Sulfate RS

USP Abacavir System Suitability Mixture RS

A mixture containing abacavir sulfate and trans-abacavir