Idarubicin Hydrochloride for Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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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 as described in Packaging and Storage Requirements 〈659〉, Injection Packaging, Packaging for constitution.

USP Reference standards 〈11〉—

USP Idarubicin Hydrochloride RS

Constituted solution—At the time of use, it meets the requirements for Injections and Implanted Drug Products 〈1〉, Speci￾c Tests, Completeness and clarity of solutions.

1 Identication—

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 Test 〈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 Tests 〈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 Determination, Method I 〈921〉: not more than 4.0%, the Test Preparation being prepared as directed for a hygroscopic specimen.

Other requirements—It meets the requirements for Uniformity of Dosage Units 〈905〉 and for Labeling 〈7〉, Labels and Labeling for Injectable Products.

2 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)(r_u​/r_s​)

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.