Printed on: Thu Feb 09 2023, 12:49:45 AM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-80B97C7C-D079-428F-955B-D6E29CA270A9_3_en-US

Printed by: Dang Van Vu Official Date: Official as of 01-May-2018 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: iz70r DOI: https://doi.org/10.31003/USPNF_M940_03_01
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Result = (r U/r S) × (C S/C U) × 100

Adenosine Injection
rU = peak response from the Sample solution
DEFINITION
Adenosine Injection is a sterile solution of Adenosine in Water rS = peak response from the Standard solution
for Injection. It may contain Sodium Chloride. It contains NLT CS = concentration of USP Adenosine RS in the
90.0% and NMT 110.0% of the labeled amount of adenosine Standard solution (mg/mL)
(C10H13N5O4). CU = nominal concentration of adenosine in the
Sample solution (mg/mL)
IDENTIFICATION
• The retention time of the adenosine peak of the Sample Acceptance criteria: 90.0%–110.0%
solution corresponds to that of the Standard solution, as
obtained in the Assay. IMPURITIES
• ORGANIC IMPURITIES
ASSAY Mobile phase, System suitability solution, Standard
• PROCEDURE solution, Chromatographic system, and System
Mobile phase: Dissolve 2.0 g of monobasic potassium suitability: Proceed as directed in the Assay.
phosphate in 800 mL of water. Add 5 mL of 1.0 M Sample solution: Nominally 0.3 mg/mL of adenosine
tetrabutylammonium dihydrogen phosphate, dilute with from a volume of Injection, in water
water to 980 mL, and mix. Add 20 mL of acetonitrile. Analysis
System suitability solution: 0.03 mg/mL each of USP Sample: Sample solution
Adenosine RS and inosine dissolved in warm water (50° to Calculate the percentage of each impurity in the volume of
55°), and diluted with water Injection taken:
Standard solution: 0.03 mg/mL of USP Adenosine RS

al
dissolved in warm water (50° to 55°), and diluted with Result = (r U/r T) × 100
water to volume. Before addition of the warm water, if
sodium chloride is present in the Injection, add 0.01 mL of a rU = peak response for each impurity
solution of sodium chloride (0.9 in 100) per mL of the rT = sum of the responses of all of the peaks
anticipated final volume of the Standard solution.
Sample solution: Nominally 0.03 mg/mL of adenosine,
from a suitable volume of Injection in water
Chromatographic system
ci Acceptance criteria
Any individual impurity: NMT 1.0%
Total impurities: NMT 1.5%
(See Chromatography á621ñ, System Suitability.)
Mode: LC SPECIFIC TESTS
• PH á791ñ: 4.5–7.5
ffi
Detector: UV 254 nm
• PARTICULATE MATTER IN INJECTIONS á788ñ: It meets the
Column: 3.9-mm × 30-cm; packing L1
requirements for small-volume injections.
Flow rate: 2.5 mL/min
• BACTERIAL ENDOTOXINS TEST á85ñ: When the product is
Injection volume: 10 µL
used for rapid intravenous injection, it contains NMT
Run time: 2.5 times the retention time of adenosine
11.62 USP Endotoxin Units/mg of adenosine. When the
System suitability
product is used for continuous peripheral intravenous
O

Samples: System suitability solution and Standard solution

infusion, it contains NMT 5.95 USP Endotoxin Units/mg of
[NOTE—The relative retention times of inosine and
adenosine.
adenosine are 0.43 and 1.0, respectively.]
• OTHER REQUIREMENTS: It meets the requirements under
Suitability requirements
Injections and Implanted Drug Products á1ñ.
Resolution: NLT 6.0 between adenosine and inosine,
System suitability solution ADDITIONAL REQUIREMENTS
Tailing factor: NMT 2.0 for the adenosine peak, System • PACKAGING AND STORAGE: Preserve in tight, single-dose
suitability solution containers, preferably of Type I glass, and store at
Relative standard deviation: NMT 1.5%, Standard controlled room temperature.
solution • USP REFERENCE STANDARDS á11ñ
Analysis USP Adenosine RS
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of
adenosine (C10H13N5O4) in the portion of Injection taken:

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