Doxorubicin Hydrochloride for Injection
»Doxorubicin Hydrochloride for Injection is a sterile mixture of Doxorubicin Hydrochloride and Lactose.It contains not less than 90.0percent and not more than 115.0percent of the labeled amount of C27H29NO11·HCl.
Caution—Great care should be taken to prevent inhaling particles of Doxorubicin Hydrochloride and exposing the skin to it.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,except that multiple-dose containers may provide for the withdrawal of not more than 100mLwhen constituted as directed in the labeling.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— Use a solution of Doxorubicin Hydrochloride for Injection containing 1.1mg of doxorubicin hydrochloride per mL:the specimen under test contains not more than 2.2USP Endotoxin Units per mg of doxorubicin hydrochloride.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined,the entire contents of all the containers being collected aseptically with the aid of 200mLof Fluid Abefore filtering.
pHá791ñ: between 4.5and 6.5,in the solution constituted as directed in the labeling,except that water is used as the diluent.
Water,Method Iá921ñ: not more than 4.0%,the Test Preparationbeing prepared as directed for a hygroscopic specimen.
Other requirements— It responds to the Identificationtest under Doxorubicin Hydrochloride,and meets the requirements for Uniformity of Dosage Units á905ñand Labelingunder Injections á1ñ.
Assay—
Mobile phase,Resolution solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Doxorubicin Hydrochloride.
Assay preparation— Dilute the contents of 1container quantitatively with Mobile phaseto obtain a solution containing about 0.1mg of doxorubicin hydrochloride per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Doxorubicin Hydrochloride.Calculate the quantity,in mg,of C27H29NO11·HCl in the container of Doxorubicin Hydrochloride for Injection taken by the formula:
(CP/1000)(L/D)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Doxorubicin Hydrochloride RSin the Standard preparation,Pis the content,in µg per mg,of C27H29NO11·HCl in the USP Doxorubicin Hydrochloride RS,Lis the labeled quantity of doxorubicin hydrochloride in the container,Dis the concentration,in mg per mL,of doxorubicin hydrochloride in the Assay preparationon the basis of the labeled quantity in the container and the extent of dilution,and rUand rSare the responses of the doxorubicin peak obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 697
Phone Number:1-301-816-8335