Ifosfamide for Injection
» Ifosfamide for Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C7H15Cl2N2O2P.
CautionGreat care should be taken in handling Ifosfamide, as it is a potent cytotoxic agent and suspected carcinogen.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1, at controlled room temperature.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
A: (See Thin-layer Chromatographic Identification Tests 201.)
Developing solvent Prepare a mixture of isopropyl alcohol and toluene (1:1).
Standard solution Dissolve 20.0 mg of USP Ifosfamide RS in 1.0 mL of alcohol.
Test solution Dissolve 20 mg of Ifosfamide for Injection in 1.0 mL of alcohol.
Procedure Apply separately 10 µL each of the Standard solution and the Test solution to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture, allow the spots to dry, and develop the plate in a paper-lined chromatographic chamber equilibrated with Developing solvent for about 15 minutes prior to use. Allow the chromatogram to develop until the solvent front has moved about 15 cm. Remove the plate, mark the solvent front, and air-dry for 5 minutes. Place the plates into a chromatographic chamber containing iodine crystals, and view the spots that develop. [noteFor better detection, overspray the iodine stain with a mixture of alcohol and water (1:1).] The RF value of the principal spot obtained from the Test solution corresponds to that obtained from the Standard solution.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, both relative to the internal standard, as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 0.125 USP Endotoxin Unit per mg.
pH 791: between 4.0 and 7.0 in a solution prepared as directed for Constituted Solutions under Injections 1, determined 30 minutes after its preparation.
Water, Method I 921: not more than 0.3%.
Other requirements It meets the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Labeling under Injections 1.
Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Ifosfamide.
Assay preparation Select an accurately counted number of containers of Ifosfamide for Injection, the combined contents of which are equivalent to about 6 g of Ifosfamide. Dissolve the contents of each container in water and combine all of the solutions in a 1000-mL volumetric flask. Rinse each container with water, and add the rinsings to the volumetric flask. Dilute with water to volume, and mix. Transfer 10.0 mL of the resulting solution to a 100-mL volumetric flask, add 4.0 mL of Internal standard solution, dilute with water to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Ifosfamide. Calculate the quantity, in g, of C7H15Cl2N2O2P in each container of Ifosfamide for Injection taken by the formula:
10(C / N)(RU / RS)in which C is the concentration, in mg per mL, of USP Ifosfamide RS in the Standard preparation; N is the number of containers selected for the Assay preparation, and RU and RS are the ratios of the responses of the ifosfamide peak to the ethylparaben peak obtained from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 2616