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.
USP Reference standards 11
USP Endotoxin RS. USP Zidovudine RS. USP Zidovudine Related Compound C RS.
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 systemProceed 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.
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.
Other requirements
It meets the requirements under Injections 1.
Assay
Mobile phase
, Standard stock solution, Zidovudine related compound C standard stock solution, and Chromatographic systemProceed 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
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 3889
Pharmacopeial Forum: Volume No. 34(3) Page 658
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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