Cytarabine for Injection
»Cytarabine for Injection contains not less than 90.0percent and not more than 110.0percent of the labeled amount of cytarabine (C9H13N3O5).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.07USP Endotoxin Unit per mg of cytarabine.
pHá791ñ: between 4.0and 6.0,in a solution containing the equivalent of 10mg of cytarabine per mL.
Water,Method Iá921ñ: not more than 3.0%.
Other requirements— It meets the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Labelingunder Injections á1ñ.The drug substance in the vial meets the requirements for Cytarabine.
Assay—
Phosphate buffer,Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Cytarabine.
Assay preparation— Separately constitute 5vials of Cytarabine for Injectionin a volume of water,accurately measured,corresponding to the volume specified in the labeling.Pool and mix the constituted solutions in a suitable container.Transfer an accurately measured volume of the constituted solution,equivalent to about 100mg of cytarabine,to a 100-mLvolumetric flask,dilute with water to 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 C9H13N3O5in the portion of constituted solution taken by the formula:
1000C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Cytarabine RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 568
Phone Number:1-301-816-8389