U.S. PHARMACOPEIA

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Zidovudine Injection
» Zidovudine Injection is a sterile solution of Zidovudine in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of zidovudine (C10H13N5O4).
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
A: Ultraviolet Absorption 197U
Medium: methanol and water (75:25).
Solution: 15 µg per mL. Obtain the test solution as follows. Mix a volume of Injection, equivalent to 20 mg of zidovudine, with 50 mL of Medium in a 200-mL volumetric flask, and dilute with Medium to volume. Dilute the resulting solution 15 in 100 with Medium, and mix.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, as obtained in the Assay.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 3.5 and 7.0, in a mixture containing a volume of Injection equivalent to 150 mg of zidovudine and 5 mL of 0.12 M potassium chloride.
Bacterial endotoxins 85 It contains not more than 1.0 USP Endotoxin Unit per mg of zidovudine.
Related compounds—
Mobile phase , Standard stock solution, Zidovudine related compound C standard stock solution, and Chromatographic system—Proceed as directed in the Assay under Zidovudine.
Standard solution— Transfer 10.0 mL of Standard stock solution and 1.0 mL of Zidovudine related compound C standard stock solution to a 100-mL volumetric flask, add 25 mL of water, mix, dilute with methanol to volume, and mix.
Test solution— Proceed as directed for Assay preparation in the Assay.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the quantity, in mg, of zidovudine related compound C (thymine) in the volume of Injection taken by the formula:
1000C [(rU / rS) / Q],
in which C is the concentration, in mg per mL, of USP Zidovudine Related Compound C RS in the Standard solution; rU and rS are the peak responses of zidovudine related compound C (thymine) obtained from the Test solution and the Standard solution, respectively; and Q is the quantity, in mg, of zidovudine in the volume of Injection taken, as determined in the Assay: not more than 1.0% is found.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Mobile phase , Standard stock solution, Zidovudine related compound C standard stock solution, and Chromatographic system—Proceed as directed in the Assay under Zidovudine.
Standard preparation— Transfer 10.0 mL of Standard stock solution and 2.0 mL of Zidovudine related compound C standard stock solution to a 100-mL volumetric flask, add 25 mL of water, mix, dilute with methanol to volume, and mix.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 25 mg of zidovudine, to a 250-mL volumetric flask, dissolve in and dilute with Mobile phase to volume, and mix.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of zidovudine (C10H13N5O4) in the volume of Injection taken by the formula:
1000C(rU / rS),
in which C is the concentration, in mg per mL, of USP Zidovudine RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 2282
Phone Number : 1-301-816-8394