Printed on: Sat Jun 26 2021, 06:03:58 AM Official Status: Currently Official on 26-Jun-2021 DocId: 1_GUID-0EBD72F7-B43B-4988-ACA7-925FBC694CAE_4_en-US

(EST)
Printed by: Nguyen Nhan Official Date: Official as of 01-May-2020 Document Type: USP @2021 USPC
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System suitability
Adenine Sample: System suitability solution
[NOTE—The relative retention times for
7-methyladenine and adenine are 0.88 and 1.0,
respectively.]
Suitability requirements
Resolution: NLT 2.0 between the 7-methyladenine and
adenine peaks
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of adenine (C5H5N5) in the
C5H5N5 135.13 portion of Adenine taken:
9H-Purin-6-amine; Result = (r U/r S) × (C S/C U) × 100
1,6-Dihydro-6-iminopurine [73-24-5].
DEFINITION rU = peak response from the Sample solution
Adenine contains NLT 98.0% and NMT 102.0% of adenine rS = peak response from the Standard solution
(C5H5N5), calculated on the dried basis. CS = concentration of USP Adenine RS in the Standard
solution (mg/mL)
IDENTIFICATION CU = concentration of Adenine in the Sample solution
Change to read: (mg/mL)

al
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared Acceptance criteria: 98.0%–102.0% on the dried basis
Spectroscopy: 197K▲ (CN 1-May-2020) IMPURITIES
• B. The retention time of the major peak of the Sample • RESIDUE ON IGNITION á281ñ: NMT 0.1%
solution corresponds to that of the Standard solution, as • RELATED COMPOUNDS
obtained in the Assay. ci Buffer solution, Mobile phase, System suitability solution,
ASSAY Standard solution, and System suitability: Proceed as
• PROCEDURE directed in the Assay.
Buffer solution: Dissolve 6.90 g of monobasic ammonium Sample solution: Dissolve 25 mg of Adenine in
phosphate in about 800 mL of water. Adjust with approximately 15 mL of boiling water. Cool, quantitatively
ammonium hydroxide to a pH of 6.2, and dilute with water transfer to a 25-mL volumetric flask, and dilute with water
ffi
to 1 L. to volume.
Mobile phase: See Table 1. Chromatographic system
(See Chromatography á621ñ, System Suitability.)
Table 1 Mode: LC
Detector: UV 240 nm
Buffer
Time Solution Acetonitrile Water Column: 4.6-mm × 25-cm; 5-µm packing L85
O

(min) (%) (%) (%) Flow rate: 1.0 mL/min

Injection volume: 20 µL
0 5 5 90
Analysis
20 5 5 90 Sample: Sample solution
Calculate the percentage of each impurity in the portion of
20.1 10 10 80
Adenine taken:
30 10 10 80
Result = (r U/r T) × 100
30.1 5 5 90

40 5 5 90 rU = peak response of each impurity from the Sample

solution
System suitability solution: 50 µg/mL each of USP rT = sum of all the peak responses from the Sample
Adenine RS and 7-methyladenine in water solution
Standard solution: 0.1 mg/mL of USP Adenine RS in water.
Acceptance criteria
If necessary, sonicate the solution at 30° until the substance
Individual impurity: NMT 0.1%
is completely dissolved.
Total impurities: NMT 2.0%
Sample solution: 0.1 mg/mL of Adenine in water. If
necessary, sonicate the solution at 30° until the substance SPECIFIC TESTS
is completely dissolved. • LOSS ON DRYING á731ñ: Dry a sample at 110° for 4 h: it loses
Chromatographic system NMT 1.0% of its weight.
(See Chromatography á621ñ, System Suitability.)
Mode: LC ADDITIONAL REQUIREMENTS
Detector: UV 260 nm • PACKAGING AND STORAGE: Preserve in well-closed
Column: 4.6-mm × 25-cm; 5-µm packing L85 containers.
Flow rate: 1.0 mL/min • USP REFERENCE STANDARDS á11ñ
Injection volume: 10 µL USP Adenine RS

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