Zidovudine Injection
»Zidovudine Injection is a sterile solution of Zidovudine in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of zidovudine (C10H13N5O4).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: Ultraviolet Absorption á197Uñ—
Medium: methanol and water (75:25).
Solution: 15µg per mL.Obtain the test solution as follows.Mix a volume of Injection,equivalent to 20mg of zidovudine,with 50mLof Mediumin a 200-mLvolumetric flask,and dilute with Mediumto volume.Dilute the resulting solution 15in 100with Medium,and mix.
B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparation,as obtained in the Assay.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 3.5and 7.0,in a mixture containing a volume of Injection equivalent to 150mg of zidovudine and 5mLof 0.12Mpotassium chloride.
Bacterial endotoxins á85ñ— It contains not more than 1.0USP Endotoxin Unit per mg of zidovudine.
Related compounds—
Mobile phase ,Standard stock solution,Zidovudine related compound Cstandard stock solution,and Chromatographic system—Proceed as directed in the Assayunder Zidovudine.
Standard solution— Transfer 10.0mLof Standard stock solutionand 1.0mLof Zidovudine related compound Cstandard stock solutionto a 100-mLvolumetric flask,add 25mLof water,mix,dilute with methanol to volume,and mix.
Test solution— Proceed as directed for Assay preparationin the Assay.
Procedure— Separately inject equal volumes (about 10µL)of the Standard solutionand the Test solutioninto 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 Cis the concentration,in mg per mL,of USP Zidovudine Related Compound C RSin the Standard solution;rUand rSare the peak responses of zidovudine related compound C(thymine)obtained from the Test solutionand the Standard solution,respectively;and Qis 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 á1ñ.
Assay—
Mobile phase ,Standard stock solution,Zidovudine related compound Cstandard stock solution,and Chromatographic system—Proceed as directed in the Assayunder Zidovudine.
Standard preparation— Transfer 10.0mLof Standard stock solutionand 2.0mLof Zidovudine related compound Cstandard stock solutionto a 100-mLvolumetric flask,add 25mLof water,mix,dilute with methanol to volume,and mix.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 25mg of zidovudine,to a 250-mLvolumetric flask,dissolve in and dilute with Mobile phaseto volume,and mix.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto 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 Cis the concentration,in mg per mL,of USP Zidovudine RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 2048
Phone Number:1-301-816-8394