U.S. PHARMACOPEIA

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Idarubicin Hydrochloride for Injection
» Idarubicin Hydrochloride for Injection is a sterile mixture of Idarubicin Hydrochloride and Lactose. It contains not less than 90.0 percent and not more than 110.0 percent 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 Solids as described under Injections 1.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification— The chromatogram of the Assay preparation obtained in the Assay exhibits a major peak for idarubicin, the retention time of which corresponds to that in the chromatogram of the Standard preparation obtained in the Assay.
Bacterial endotoxins 85— It contains not more than 8.9 USP Endotoxin Units per mg of idarubicin hydrochloride, a solution of Idarubicin Hydrochloride for Injection containing 0.07 mg of idarubicin hydrochloride per mL being used in the Test Procedure.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.0 and 7.0, in a solution constituted as directed in the labeling, water being used as the diluent.
Water, Method I 921: not more than 4.0%, the Test Preparation being prepared as directed for a hygroscopic specimen.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Uniformity of Dosage Units 905 and for Labeling under Injections 1.
Assay—
Mobile phase, Diluent, Standard preparation, Resolution solution, and Chromatographic system— Proceed as directed in the Assay under Idarubicin Hydrochloride.
Assay preparation— Dilute the contents of 1 container of Idarubicin Hydrochloride for Injection quantitatively with Diluent to obtain a solution containing about 0.5 mg of idarubicin hydrochloride per mL.
Procedure— Proceed as directed for Procedure under 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 C is the concentration, in µg per mL, of idarubicin hydrochloride (C26H27NO9·HCl) in the Standard preparation; L is the labeled quantity, in mg, of idarubicin hydrochloride in the container; D is the concentration, in mg per mL, of idarubicin hydrochloride in the Assay preparation on the basis of the labeled quantity in the container and the extent of dilution; and rU and rS are the responses of the idarubicin peak obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1105
Phone Number : 1-301-816-8223