Daunorubicin 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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Daunorubicin Hydrochloride for Injection is a sterile mixture of Daunorubicin Hydrochloride and Mannitol. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C₂₇H₂₉NO₁₀

1 Packaging and storage-

Preserve as described in Packaging and Storage Requirements (659), Injection Packaging, Packaging for constitution; protect from light.

1.1 USP REFERENCE STANDARDS (11)-

USP Daunorubicin Hydrochloride RS

2 Constituted solution-

At the time of use, it meets the requirements for Injections and Implanted Drug Products (1), Specific Tests, Completenes: and clarity of solutions.

3 Identification-

The retention time of the main peak obtained with the Assay preparation corresponds to that obtained with the Standard preparation as directed in the Assay.

3.1 BACTERIAL ENDOTOXINS TEST (85)-

It contains not more than 4.3 USP Endotoxin Units per mg of daunorubicin.

3.2 PH (791):

between 4.5 and 6.5, in the solution constituted as directed in the labeling.

3.3 WATER DETERMINATION, Method I (921):

not more than 3.0%, the Test Preparation being prepared as directed for a hygroscopic specimen.

4 Other requirements-

It meets the requirements under Injections and Implanted Drug Products (1).

5 Assay-

Mobile phase, Standard preparation, Resolution solution, and Chromatographic system-Prepare as directed in the Assay under Daunorubicin Hydrochloride.

Assay preparation-Transfer the contents of 1 vial of Daunorubicin Hydrochloride for Injection with the aid of Mobile phase to an appropriate volumetric flask, and dilute with Mobile phase to volume to obtain a solution containing about 0.25 mg of daunorubicin per mL.

Procedure-Proceed as directed for Procedure in the Assay under Daunorubicin Hydrochloride. Calculate the quantity, in mg, of C₂₇H₂₉NO₁₀ in the vial of Daunorubicin Hydrochloride for Injection taken by the formula:

(CV/1000)(r_u/r_s)

in which V is the volume, in mL, of the Assay preparation, and the other terms are as defined therein.