Daunorubicin Hydrochloride for Injection
»Daunorubicin Hydrochloride for Injection is a sterile mixture of Daunorubicin Hydrochloride and Mannitol.It contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of C27H29NO10.
Packaging and storage— Preserve in light-resistant 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 retention time of the main peak obtained with the Assay preparationcorresponds to that obtained with the Standard preparationas directed in the Assay.
Bacterial endotoxins á85ñ— It contains not more than 4.3USP Endotoxin Units per mg of daunorubicin.
pHá791ñ: between 4.5and 6.5,in the solution constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 3.0%,the Test Preparationbeing prepared as directed for a hygroscopic specimen.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Daunorubicin Hydrochloride.
Assay preparation— Transfer the contents of 1vial of Daunorubicin Hydrochloride for Injection with the aid of Mobile phaseto an appropriate volumetric flask,and dilute with Mobile phaseto volume to obtain a solution containing about 0.25mg of daunorubicin per mL.
Procedure— Proceed as directed for Procedurein the Assayunder Daunorubicin Hydrochloride.Calculate the quantity,in mg,of C27H29NO10in the vial of Daunorubicin Hydrochloride for Injection taken by the formula:
(CV/1000)(rU/rS),
in which Vis the volume,in mL,of the Assay preparation,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 574
Phone Number:1-301-816-8335