Cytarabine for Injection

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

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

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1 DEFINITION 

13 Cytarabine for Injection contains NLT 90.0% and NMT 110.0% of the labeled amount of cytarabine (C₉H₁₃N₃O₅)

2 IDENTIFICATION

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

3 ASSAY

3.1 PROCEDURE

Solution A: 0.73 g/L of monobasic sodium phosphate and 1.4 g/L of dibasic sodium phosphate in water

Mobile phase: Methanol and Solution A (5:95)

Standard solution: 0.1 mg/mL of USP Cytarabine RS in water

System suitability solution: 0.1 mg/mL each of USP Uracil Arabinoside RS and USP Cytarabine RS in water prepared as follows. Dissolve USP Uracil Arabinoside RS in Standard solution.

Sample solution: 0.1 mg/mL of cytarabine in water prepared as follows. Separately constitute 5 vials of Cytarabine for Injection in a volume of water corresponding to the volume specified in the labeling. Pool and mix the constituted solutions in a suitable container. Transfer a volume of the constituted solution, nominally equivalent to 100 mg of cytarabine, into a 100-mL volumetric flask, and dilute with water to volume. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, and dilute with water to volume.

3.1.1 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm x 25-cm; packing L1

Flow rate: 1.0 mL/min

Injection volume: 10 µL

After chromatography has been completed, flush the column with a mixture of water and methanol (7:3).

3.1.2 System suitability

Samples: Standard solution and System suitability solution

[NOTE-The relative retention times for cytarabine and uracil arabinoside are about 1.0 and 1.3, respectively.]

3.1.3 Suitability requirements

Resolution: NLT 2.5 between cytarabine and uracil arabinoside, System suitability solution

Relative standard deviation: NMT 2.0%, Standard solution

3.1.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of cytarabine (C₉H₁₃N₃O₅) in the portion of Cytarabine for Injection taken:

                Result = (r_U/r_S) x (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 Cytarabine RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

UNIFORMITY OF DOSAGE UNITS (905): Meets the requirements

5 SPECIFIC TESTS

PH (791)

Sample solution: 10 mg/mL of cytarabine

Acceptance criteria: 4.0-6.0

WATER DETERMINATION, Method (921): NMT 3.0%

BACTERIAL, ENDOTOXINS TEST (85): It contains NMT 0.07 USP Endotoxin Unit/mg of cytarabine.

CONSTITUTED SOLUTION: At the time of use, it meets the requirements in Injections and Implanted Drug Products (1), Specific Tests. Completeness and clarity of solutions.

STERILITY TESTS (71): Meets the requirements

OTHER REQUIREMENTS: The drug substance in the vial meets the requirements for Cytarabine.

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve as described in Packaging and Storage Requirements (659), Injection Packaging.

LABELING: It meets the requirements in Labeling (7). Labels and Labeling for Injectable Products.

USP REFERENCE STANDARDS (11)

USP Cytarabine RS

USP Uracil Arabinoside RS

2,4(1H,3H)-Pyrimidinedione, 1-beta-p-arabinofuranosyl-.

C₉H₁₂N₂O₆           244.20