Cyclophosphamide for Injection
» Cyclophosphamide for Injection is a sterile mixture of Cyclophosphamide with or without a suitable diluent. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of anhydrous cyclophosphamide (C7H15Cl2N2O2P).
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1. Storage at a temperature not exceeding 25 is recommended. It will withstand brief exposure to temperatures up to 30, but is to be protected from temperatures above 30.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
A: It responds to the Thin-layer Chromatographic Identification Test 201, a solution of it in chloroform, equivalent to 20 mg of cyclophosphamide per mL, filtered if necessary, being used as the test solution. Apply 5 µL of the test solution and the Standard solution, use a solvent system consisting of a mixture of chloroform, methanol, and ammonium hydroxide (75:20:5), and visualize the spots by placing the plate in an iodine chamber.
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 0.20 USP Endotoxin Unit per mg of cyclophosphamide.
pH 791: between 3.0 and 9.0, but the range does not exceed 3 pH units, in a solution containing the equivalent of 20 mg of anhydrous cyclophosphamide per mL, determined 30 minutes after its preparation.
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, and Standard preparation Prepare as directed in the Assay under Cyclophosphamide.
Assay preparation Accurately weigh a portion of Cyclophosphamide for Injection, equivalent to about 200 mg of anhydrous cyclophosphamide, and proceed as directed for Assay preparation in the Assay under Cyclophosphamide.
Chromatographic system Proceed as directed for Chromatographic system in the Assay under Cyclophosphamide.
Procedure Proceed as directed for Procedure in the Assay under Cyclophosphamide. Calculate the quantity, in mg, of C7H15Cl2N2O2P in the portion of Cyclophosphamide for Injection taken by the formula:
400C(RU / RS)in which the terms are as defined therein.
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USP35NF30 Page 2790