3480注射用异环磷酰胺.pdfVIP

USP 35 Official Monographs / Ifosfamide 3479 ograph, record the chromatograms, and measure the areas of Packaging and storage—Preserve ontainers for Sterile the peaks due to 2-chloroethylamine hydrochloride. Calculate Solids as described under Injections 1, at controlled room the percentage of 2-chloroethylamine hydrochloride in the por- temperature. tion of Ifosfamide taken by the formula: USP Reference standards 11— 1000(C / W)(r / r ) USP Endotoxin RS U S USP Ifosfamide RS in which C is the concentration, in mg per mL, of 2-chloroeth- Constituted solution—At the time of use, it meets the re- ylamine hydrochloride in the Standard solution;W is the weight, quirements for Constituted Solutions under Injections 1. in mg, of Ifosfamide taken; and rU and rS are the areas of the 2- Identification— chloroethylamine peaks obtained from the Test solution and the Standard solution, respectively: not more than 0.25% of 2-chlo- A: (See Thin-layer Chromatographic Identification Tests 201.) roethylamine hydrochloride is found. Develo solvent—Prepare a mixture of isopropyl alcohol Other requirements—Where the label states that Ifosfamide and toluene (1:1). is sterile, it meets the requirements for Sterility Tests 71and for Standard solution—Dissolve 20.0 mg of USP Ifosfamide RS in Bacterial endotoxins under Ifosfamide for In