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(EST)
Printed by: Nguyen Nhan Official Date: Official as of 01-May-2013 Document Type: USP @2021 USPC
1

rS = peak response of abacavir from the Standard

Abacavir Tablets solution
DEFINITION CS = concentration of abacavir sulfate in the Standard
Abacavir Tablets contain Abacavir Sulfate equivalent to NLT solution (mg/mL)
90.0% and NMT 110.0% of the labeled amount of abacavir CU = nominal concentration of abacavir in the Sample
(C14H18N6O). solution (mg/mL)
Mr1 = molecular weight of abacavir multiplied by 2,
IDENTIFICATION 572.66
• A. The retention time of the major peak of the Sample Mr2 = molecular weight of abacavir sulfate, 670.74
solution corresponds to that of the Standard solution, as
obtained in the Assay. Acceptance criteria: 90.0%–110.0%
ASSAY PERFORMANCE TESTS
• PROCEDURE • DISSOLUTION á711ñ
Diluent: 1.0 mL of phosphoric acid in 1 L of water Medium: 0.1 N hydrochloric acid; 900 mL
Solution A: Trifluoroacetic acid and water (0.05: 99.95) Apparatus 2: 75 rpm
Solution B: Methanol and water (85:15) Time: 15 min
Mobile phase: See Table 1. Standard solution: 0.39 mg/mL of USP Abacavir Sulfate RS
in Medium
Table 1 Sample solution: Pass a portion of the solution under test
Time Solution A Solution B through a suitable filter of 0.45-µm pore size.
(min) (%) (%) Instrumental conditions
Mode: UV

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0 95 5
Analytical wavelength: 254 nm
20 70 30 Blank: Medium
Calculate the percentage of the labeled amount of
35 10 90
abacavir (C14H18N6O) dissolved:
40 10 90

41

50
95

95
5

5
ci AU
AS
Result = (AU/AS) × (CS/L) × (Mr1/Mr2) × V × 100

= absorbance of the Sample solution

= absorbance of the Standard solution
System suitability solution: 0.2 mg/mL of USP Abacavir CS = concentration of the Standard solution (mg/mL)
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System Suitability Mixture RS in Diluent L = label claim (mg/Tablet)
Standard solution: 0.21 mg/mL of abacavir sulfate in Mr1 = molecular weight of abacavir multiplied by 2,
Diluent (equivalent to 0.18 mg/mL of abacavir), from USP 572.66
Abacavir Sulfate RS Mr2 = molecular weight of abacavir sulfate, 670.74
Sample stock solution: Transfer the equivalent to 1500 mg V = volume of Medium, 900 mL
of abacavir, from a portion of Tablets, into a 250-mL
O

volumetric flask. Add 150 mL of Diluent. Shake Tolerances: NLT 80% (Q) of the labeled amount of abacavir
mechanically for 45 min. Dilute with Diluent to volume. (C14H18N6O) is dissolved.
Pass a portion through a suitable filter of 0.45-µm or finer • UNIFORMITY OF DOSAGE UNITS á905ñ: Meet the
pore size. Discard the first 3 mL of the filtrate. requirements
Sample solution: 0.18 mg/mL of abacavir in Diluent using
the filtrate obtained in the Sample stock solution IMPURITIES
Chromatographic system • ORGANIC IMPURITIES
(See Chromatography á621ñ, System Suitability.) Diluent, Solution A, Solution B, Mobile phase, System
Mode: LC suitability solution, Standard solution, Sample solution,
Detector: UV 254 nm and Chromatographic system: Proceed as directed in the
Column: 3.9-mm × 15-cm; packing L1 Assay.
Flow rate: 0.8 mL/min Analysis
Injection volume: 10 µL [NOTE—Record the chromatograms for 2.5 times the
System suitability retention time of abacavir.]
Samples: System suitability solution and Standard solution Samples: Standard solution and Sample solution
Suitability requirements Calculate the percentage of each impurity in the portion
Resolution: NLT 1.5 between abacavir and of Tablets taken:
trans-abacavir, System suitability solution
Result = (rU/rS) × (CS/CU) × (1/F) × (Mr1/Mr2) × 100
Relative standard deviation: NMT 2.0%, Standard
solution rU = peak response of each impurity from the Sample
Analysis solution
Samples: Standard solution and Sample solution rS = peak response of abacavir from the Standard
Calculate the percentage of the labeled amount of solution
abacavir (C14H18N6O) in the portion of Tablets taken: CS = concentration of USP Abacavir Sulfate RS in the
Standard solution (mg/mL)
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100 CU = nominal concentration of abacavir in the Sample
solution (mg/mL)
rU = peak response of abacavir from the Sample
F = relative response factor for each impurity (see
solution
Table 2)

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Printed on: Sat Jun 26 2021, 05:42:12 AM Official Status: Currently Official on 26-Jun-2021 DocId: 1_GUID-827EB207-107E-47DA-A4F6-BB0078A8FE23_1_en-US
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Printed by: Nguyen Nhan Official Date: Official as of 01-May-2013 Document Type: USP @2021 USPC
2

Mr1 = molecular weight of abacavir multiplied by 2, Table 2 (continued)

572.66 Relative Relative Acceptance
Mr2 = molecular weight of abacavir sulfate, 670.74 Retention Response Criteria,
Name Time Factor NMT (%)
Acceptance criteria: See Table 2. Total impurities — — 1.0

Table 2 a N6-Cyclopropyl-9H-purine-2,6-diamine.
b [(1S,4R)-4-(2,6-Diamino-9H-purin-9-yl)-cyclopent-2-enyl]methanol.
Relative Relative Acceptance
c {(1R,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-cyclopent-2-enyl}
Retention Response Criteria,
Name Time Factor NMT (%) methanol.
d Process impurity monitored in the drug substance and not included in the total
Cyclopropyldiaminopurine impurities.
abacavira 0.57 1.4 0.2 e N6-Cyclopropyl-9-{(1R,4S)-4-[(2,5-diamino-6-chloropyrimidin-4-yloxy)
methyl]cyclopent-2-enyl}-9H-purine-2,6-diamine.
Descyclopropyl abacavirb 0.68 1.0 0.2
Abacavir 1.0 — — ADDITIONAL REQUIREMENTS
trans-Abacavir c, d
1.04 — —
• PACKAGING AND STORAGE: Preserve in well-closed
containers. Store at room temperature.
O-Pyrimidine derivative abaca-
— — • USP REFERENCE STANDARDS á11ñ
vird, e 1.24 USP Abacavir Sulfate RS
Any other individual impurity — 1.0 0.2 USP Abacavir System Suitability Mixture RS
—A mixture of abacavir sulfate and trans-abacavir.

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