Idarubicin Hydrochloride for Injection
»Idarubicin Hydrochloride for Injection is a sterile mixture of Idarubicin Hydrochloride and Lactose.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C26H27NO9·HCl.
Caution—Great care should be taken to prevent inhaling particles of Idarubicin Hydrochloride and exposing the skin to it.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— The chromatogram of the Assay preparationobtained in the Assayexhibits a major peak for idarubicin,the retention time of which corresponds to that in the chromatogram of the Standard preparationobtained in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 8.9USP Endotoxin Units per mg of idarubicin hydrochloride,a solution of Idarubicin Hydrochloride for Injection containing 0.07mg of idarubicin hydrochloride per mLbeing used in the Test Procedure.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 5.0and 7.0,in a solution constituted as directed in the labeling,water being 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 meets the requirements for Uniformity of Dosage Units á905ñand for Labelingunder Injections á1ñ.
Assay—
Mobile phase,Diluent,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Idarubicin Hydrochloride.
Assay preparation— Dilute the contents of 1container of Idarubicin Hydrochloride for Injection quantitatively with Diluentto obtain a solution containing about 0.5mg of idarubicin hydrochloride per mL.
Procedure— Proceed as directed for Procedureunder Idarubicin Hydrochloride.Calculate the quantity,in mg,of C26H27NO9·HCl in the container of Idarubicin Hydrochloride for Injection taken by the formula:
(C/1000)(L/D)(rU/rS),
in which Cis the concentration,in µg per mL,of idarubicin hydrochloride (C26H27NO9·HCl)in the Standard preparation;Lis the labeled quantity,in mg,of idarubicin hydrochloride in the container;Dis the concentration,in mg per mL,of idarubicin 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 idarubicin 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 996
Phone Number:1-301-816-8335