Cytarabine for Injection
» Cytarabine for Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of cytarabine (C9H13N3O5).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 0.07 USP Endotoxin Unit per mg of cytarabine.
pH 791: between 4.0 and 6.0, in a solution containing the equivalent of 10 mg of cytarabine per mL.
Water, Method I 921: not more than 3.0%.
Other requirements It meets the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Labeling under Injections 1. The drug substance in the vial meets the requirements for Cytarabine.
Phosphate buffer, Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Cytarabine.
Assay preparation Separately constitute 5 vials of Cytarabine for Injection in 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 100 mg of cytarabine, to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with water 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 C9H13N3O5 in the portion of constituted solution taken by the formula:
1000C(rU / rS)in which C is the concentration, in mg per mL, of USP Cytarabine RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 2051Pharmacopeial Forum: Volume No. 33(1) Page 51