U.S. PHARMACOPEIA

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Doxorubicin Hydrochloride for Injection
» Doxorubicin Hydrochloride for Injection is a sterile mixture of Doxorubicin Hydrochloride and Lactose. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C27H29NO11·HCl.
Caution—Great care should be taken to prevent inhaling particles of Doxorubicin Hydrochloride and exposing the skin to it.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, except that multiple-dose containers may provide for the withdrawal of not more than 100 mL when constituted as directed in the labeling.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85— Use a solution of Doxorubicin Hydrochloride for Injection containing 1.1 mg of doxorubicin hydrochloride per mL: the specimen under test contains not more than 2.2 USP Endotoxin Units per mg of doxorubicin hydrochloride.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, the entire contents of all the containers being collected aseptically with the aid of 200 mL of Fluid A before filtering.
pH 791: between 4.5 and 6.5, in the solution constituted as directed in the labeling, except that water is 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 responds to the Identification test under Doxorubicin Hydrochloride, and meets the requirements for Uniformity of Dosage Units 905 and Labeling under Injections 1.
Assay—
Mobile phase, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Doxorubicin Hydrochloride.
Assay preparation— Dilute the contents of 1 container quantitatively with Mobile phase to obtain a solution containing about 0.1 mg of doxorubicin hydrochloride per mL.
Procedure— Proceed as directed for Procedure in the Assay under Doxorubicin Hydrochloride. Calculate the quantity, in mg, of C27H29NO11·HCl in the container of Doxorubicin Hydrochloride for Injection taken by the formula:
(CP / 1000)(L / D)(rU / rS),
in which C is the concentration, in mg per mL, of USP Doxorubicin Hydrochloride RS in the Standard preparation, P is the content, in µg per mg, of C27H29NO11·HCl in the USP Doxorubicin Hydrochloride RS, L is the labeled quantity of doxorubicin hydrochloride in the container, D is the concentration, in mg per mL, of doxorubicin 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 doxorubicin 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 761
Phone Number : 1-301-816-8223