Zidovudine 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

Zidovudine Injection is a sterile solution of Zidovudine in Water for Injection. It contains NLT 90.0% and NMT 110.0% of the labeled amount of zidovudine (C₁₀H₁₃N₅O₄).

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020)

Solution A: Methanol and water (75:25)

Sample solution: Nominally 15 µg/mL of zidovudine from Injection in Solution A

Acceptance criteria: Meets the requirements

B. 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

Procedure

Mobile phase: Methanol and water (20:80)

Standard stock solution: 1.0 mg/mL of USP Zidovudine RS in methanol

Zidovudine related compound C standard stock solution: 0.2 mg/mL of USP Zidovudine Related Compound C RS in methanol prepared as follows. Transfer 20 mg of USP Zidovudine Related Compound C RS to a 100-mL volumetric flask, add 75 mL of methanol, sonicate for 15 min, and dilute with methanol to volume.

Standard solution: 0.1 mg/mL of USP Zidovudine RS and 4 µg/mL of USP Zidovudine Related Compound C RS prepared as follows. Transfer a suitable volume of Standard stock solution and Zidovudine related compound C standard stock solution to a suitable volumetric ask. Add 25% of the ask volume of water, and dilute with methanol to volume.

Sample solution: Nominally 0.1 mg/mL of zidovudine from Injection in Mobile phase

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 265 nm

Columns

Guard: Recommended dimensions are 3.2-mm × 1.5-cm; packing L1.

Analytical: 4.0-mm × 25-cm; packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

3.2 System suitability

Sample: Standard solution

[Note—The relative retention times for zidovudine related compound C and zidovudine are about 0.2 and 1.0, respectively.] Suitability requirements

Resolution: NLT 5.0 between zidovudine and zidovudine related compound C

Tailing factor: NMT 1.5 for the zidovudine peak

Relative standard deviation: NMT 2.0% for the zidovudine peak

3.3 Analysis

Samples: Standard solution and Sample solution

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

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

r_U = peak response of zidovudine from the Sample solution

r_S = peak response of zidovudine from the Standard solution

C_S = concentration of the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%–110.0%

4 IMPURITIES

Organic Impurities

Mobile phase, Standard stock solution, Zidovudine related compound C standard stock solution, Sample solution, Chromatographic system, and System suitability: Proceed as directed in the Assay.

Standard solution: 0.1 mg/mL of USP Zidovudine RS and 2 µg/mL of USP Zidovudine Related Compound C RS prepared as follows. Transfer a suitable volume of Standard stock solution and Zidovudine related compound C standard stock solution to a suitable volumetric ask. Add 25% of the ask volume of water, and dilute with methanol to volume.

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of zidovudine related compound C in the portion of Injection taken:

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

r_U = peak response of zidovudine related compound C from the Sample solution

r_S = peak response of zidovudine related compound C from the Standard solution

C_S = concentration of USP Zidovudine Related Compound C RS in the Standard solution (mg/mL)

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

Acceptance criteria: NMT 1.0%

5 SPECIFIC TESTS

Sterility Tests 〈71〉: Meets the requirement when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration

pH 〈791〉

Sample solution: A mixture containing a volume of Injection equivalent to 150 mg of zidovudine and 5 mL of 0.12 M potassium chloride

Acceptance criteria: 3.5–7.0

Bacterial Endotoxins Test 〈85〉: NMT 1.0 USP Endotoxin Unit/mg of zidovudine

Other Requirements: Meets the requirements in Injections and Implanted Drug Products 〈1〉

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Zidovudine RS

USP Zidovudine Related Compound C RS

Thymine.

C₅H₆N₂O₂  126.12