Cyclophosphamide for Injection
»Cyclophosphamide for Injection is a sterile mixture of Cyclophosphamide with or without a suitable diluent.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of anhydrous cyclophosphamide (C7H15Cl2N2O2P).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.Storage at a temperature not exceeding 25is recommended.It will withstand brief exposure to temperatures up to 30,but is to be protected from temperatures above 30.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification—
A: It responds to the Thin-layer Chromatographic Identification Test á201ñ,a solution of it in chloroform,equivalent to 20mg of cyclophosphamide per mL,filtered if necessary,being used as the test solution.Apply 5µLof 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 preparationcorresponds to that of the Standard preparation,both relative to the internal standard,as obtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 0.20USP Endotoxin Unit per mg of cyclophosphamide.
pHá791ñ: between 3.0and 9.0,but the range does not exceed 3pHunits,in a solution containing the equivalent of 20mg of anhydrous cyclophosphamide per mL,determined 30minutes after its preparation.
Other requirements— It meets the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Labelingunder Injections á1ñ.
Assay—
Mobile phase,Internal standard solution,and Standard preparation— Prepare as directed in the Assayunder Cyclophosphamide.
Assay preparation— Accurately weigh a portion of Cyclophosphamide for Injection,equivalent to about 200mg of anhydrous cyclophosphamide,and proceed as directed for Assay preparationin the Assayunder Cyclophosphamide.
Chromatographic system— Proceed as directed for Chromatographic systemin the Assayunder Cyclophosphamide.
Procedure— Proceed as directed for Procedurein the Assayunder Cyclophosphamide.Calculate the quantity,in mg,of C7H15Cl2N2O2Pin the portion of Cyclophosphamide for Injection taken by the formula:
400C(RU/RS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 558
Phone Number:1-301-816-8389