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 90.0 percent and not more than 115.0 percent of the labeled amount of C27H29NO10.
Packaging and storage Preserve in light-resistant Containers for Sterile Solids as described under Injections 1.
USP Reference standards 11
USP Endotoxin RS
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
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.
Bacterial endotoxins 85 It contains not more than 4.3 USP Endotoxin Units per mg of daunorubicin.
pH 791: between 4.5 and 6.5, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 3.0%, the Test Preparation being prepared as directed for a hygroscopic specimen.
Other requirements It meets the requirements under Injections 1.
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)(rU / rS)in which V is the volume, in mL, of the Assay preparation, and the other terms are as defined therein.
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USP35NF30 Page 2811