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(EST)
Printed by: Nguyen Nhan Official Date: Official Prior to 2013 Document Type: USP @2021 USPC
1

Mr1 = molecular weight of abacavir mutiplied by 2,

Abacavir Oral Solution 572.66
DEFINITION Mr2 = molecular weight of abacavir sulfate, 670.74
Abacavir Oral Solution contains NLT 90.0% and NMT 110.0%
of the labeled amount of abacavir (C14H18N6O). Acceptance criteria: 90.0%–110.0%
PERFORMANCE TESTS
IDENTIFICATION
• DELIVERABLE VOLUME á698ñ: Meets the requirements
• The retention time of the major peak of the Sample solution
corresponds to that of the Standard solution, as obtained in IMPURITIES
the Assay. ORGANIC IMPURITIES
• Procedure
ASSAY
• PROCEDURE Solution A, Solution B, Diluent, Mobile phase, System
Solution A: Trifluoroacetic acid and water (0.05: 99.95) suitability solution, Standard solution, Sample solution,
Solution B: Methanol and water (17:3) Chromatographic system, and System suitability:
Proceed as directed in the Assay.
Diluent: 1 mL of phosphoric acid diluted with water to
1000 mL Sensitivity solution: 0.2 µg/mL of USP Abacavir Sulfate RS in
Diluent, from the Standard solution. [NOTE—The
Mobile phase: See the gradient table below.
concentration of this solution is 0.05% of the nominal
concentration of the Sample solution.]
Time Solution A Solution B Analysis
(min) (%) (%)
Samples: Diluent, Standard solution, Sample solution, and
0 95 5 Sensitivity solution. [NOTE—In the Sample solution disregard

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any peaks corresponding to peaks identified in the Diluent
20 70 30
and any peak with a peak area less than the abacavir peak
35 10 90 area in the Sensitivity solution.]
Calculate the percentage of each impurity in the portion of
40 10 90
ci Oral Solution taken:
41 0 100
Result = (rU/rS) × (CS/CU) × (1/F) × (Mr1/Mr2) × 100
50 0 100

51 95 5 rU = peak area of abacavir from the Sample solution

rS = peak area of abacavir from the Standard solution
55 95 5
CS = concentration of USP Abacavir Sulfate RS in the
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Standard solution (mg/mL)
System suitability solution: 0.2 mg/mL of USP Abacavir CU = nominal concentration of abacavir in the Sample
System Suitability Mixture RS in Diluent solution (mg/mL)
Standard solution: 0.46 mg/mL of USP Abacavir Sulfate RS F = relative response factor for each impurity from
in Diluent Impurity Table 1
Sample solution: Equivalent to 0.4 mg/mL of abacavir in Mr1 = molecular weight of abacavir mutiplied by 2,
O

Diluent, from Oral Solution. [NOTE—Sonicate, if necessary.] 572.66

Chromatographic system Mr2 = molecular weight of abacavir sulfate, 670.74
(See Chromatography á621ñ, System Suitability.)
Mode: LC Acceptance criteria
Detector: UV 254 nm Individual impurities: See Impurity Table 1.
Column: 3.9-mm × 15-cm; 5-µm packing L1 Total impurities: NMT 2.0%
Column temperature: 30°
Flow rate: 0.8 mL/min Impurity Table 1
Injection size: 10 µL
Relative Relative Acceptance
System suitability Retention Response Criteria,
Samples: System suitability solution and Standard solution Name Time Factor NMT (%)
Suitability requirements
Cyclopropyldiaminopur-
Resolution: NLT 1.5 between abacavir and ine abacavira 0.57 1.4 0.3
trans-abacavir, System suitability solution
Relative standard deviation: NMT 2.0%, Standard Descyclopropyl abacavirb 0.68 1.0 0.8
solution Abacavir 1.00 — —
Analysis
Samples: Standard solution and Sample solution trans-Abacavirc 1.04 1.0 —
Calculate the percentage of C14H18N6O in the portion of Any individual unspeci-
Oral Solution taken: fied impurity — 1.0 0.2

Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100 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}
rU = peak area of abacavir from the Sample solution
methanol. It is a process impurity and monitored in the drug substance.
rS = peak area of abacavir from the Standard solution
CS = concentration of USP Abacavir Sulfate RS in the
SPECIFIC TESTS
Standard solution (mg/mL)
• MICROBIAL ENUMERATION TESTS á61ñ and TESTS FOR
CU = nominal concentration of abacavir in the Sample
SPECIFIED MICROORGANISMS á62ñ: The total aerobic
solution (mg/mL)
microbial count does not exceed 100 cfu/mL, and the total
combined molds and yeast count does not exceed 10 cfu/

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Printed by: Nguyen Nhan Official Date: Official Prior to 2013 Document Type: USP @2021 USPC
2

mL. It also meets the requirement for absence of • USP REFERENCE STANDARDS á11ñ
Escherichia coli. USP Abacavir Sulfate RS
• PH á791ñ: 3.8–4.5 USP Abacavir System Suitability Mixture RS
A mixture containing abacavir sulfate and trans-abacavir
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed
containers. Store at controlled room temperature.

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