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Doxorubicin Hydrochloride Injection
» Doxorubicin Hydrochloride Injection is a sterile solution of Doxorubicin Hydrochloride in Sterile Water for Injection made isoosmotic with Sodium Chloride, Dextrose, or other suitable added substances. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C27H29NO11·HCl.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass, protected from light. Store in a refrigerator. Injection may be packaged in multiple-dose containers not exceeding 100 mL in volume.
Identification— When chromatographed as directed in the Assay, the Assay preparation exhibits a major peak for doxorubicin, the retention time of which corresponds to that exhibited by the Standard preparation.
Bacterial endotoxins 85— Use a test solution prepared by diluting Doxorubicin Hydrochloride Injection with Sterile Water for Injection to obtain a concentration of 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.
pH 791: between 2.5 and 4.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements 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 an accurately measured volume of Injection, equivalent to not less than 2 mg of doxorubicin hydrochloride, quantitatively with Mobile phase to obtain a solution containing about 0.1 mg of doxorubicin hydrochloride per mL, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Doxorubicin Hydrochloride. Calculate the quantity, in mg, of C27H29NO11·HCl in each mL of the Injection taken by the formula:
(CP / 1000)(L / D)(rU / rS),
in which L is the labeled quantity, in mg per mL, of doxorubicin hydrochloride in the Doxorubicin Hydrochloride Injection taken, D is the concentration, in mg per mL, of doxorubicin hydrochloride in the Assay preparation, on the basis of the labeled quantity in the volume of Injection taken and the extent of dilution, and the other terms are as defined therein.
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