Adenosine Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Adenosine Injection is a sterile solution of Adenosine in Water for Injection. It may contain Sodium Chloride. It contains NLT 90.0% and NMT 110.0% of the labeled amount of adenosine (C₁₀H₁₃N₅O₄).

2 IDENTIFICATION

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

3 ASSAY

3.1 Procedure

Mobile phase: Dissolve 2.0 g of monobasic potassium phosphate in 800 mL of water. Add 5 mL of 1.0 M tetrabutylammonium dihydrogen phosphate, dilute with water to 980 mL, and mix. Add 20 mL of acetonitrile.

System suitability solution: 0.03 mg/mL each of USP Adenosine RS and inosine dissolved in warm water (50° to 55°), and diluted with water Standard solution: 0.03 mg/mL of USP Adenosine RS dissolved in warm water (50° to 55°), and diluted with water to volume. Before addition of the warm water, if sodium chloride is present in the Injection, add 0.01 mL of a solution of sodium chloride (0.9 in 100) per mL of the anticipated nal volume of the Standard solution.

Sample solution: Nominally 0.03 mg/mL of adenosine, from a suitable volume of Injection in water

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm × 30-cm; packing L1

Flow rate: 2.5 mL/min

Injection volume: 10 µL

Run time: 2.5 times the retention time of adenosine

3.3 System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times of inosine and adenosine are 0.43 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 6.0 between adenosine and inosine, System suitability solution

Tailing factor: NMT 2.0 for the adenosine peak, System suitability solution

Relative standard deviation: NMT 1.5%, Standard solution

3.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of adenosine (C10H13N5O4) in the portion of Injection taken:

Result = (r_U /r_S ) × (C_S /C_U ) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Adenosine RS in the Standard solution (mg/mL)

C_U = nominal concentration of adenosine in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 IMPURITIES

4.1 Organic Impurities

Mobile phase, System suitability solution, Standard solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Sample solution: Nominally 0.3 mg/mL of adenosine from a volume of Injection, in water

4.2 Analysis

Sample: Sample solution

Calculate the percentage of each impurity in the volume of Injection taken:

Result = (r_U /r_T ) × 100

r_U = peak response for each impurity

r_T = sum of the responses of all of the peaks  

4.3 Acceptance criteria

Any individual impurity: NMT 1.0%

Total impurities: NMT 1.5%

5 SPECIFIC TESTS

pH 〈791〉: 4.5–7.5

Particulate Matter in Injections 〈788〉: It meets the requirements for small-volume injections.

Bacterial Endotoxins Test 〈85〉: When the product is used for rapid intravenous injection, it contains NMT 11.62 USP Endotoxin Units/mg of adenosine. When the product is used for continuous peripheral intravenous infusion, it contains NMT 5.95 USP Endotoxin Units/mg of adenosine.

Other Requirements: It meets the requirements under Injections and Implanted Drug Products 〈1〉.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, single-dose containers, preferably of Type I glass, and store at controlled room temperature.

USP Reference Standards 〈11〉

USP Adenosine RS