Mitoxantrone Injection
» Mitoxantrone Injection is a sterile solution of Mitoxantrone Hydrochloride in Water for Injection. It contains the equivalent of not less than 90.0 percent and not more than 105.0 percent of the labeled amount of mitoxantrone (C22H28N4O6).
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
Labeling— Label Injection to state both the content of the active moiety and the name of the salt used in formulating the article. Label Mitoxantrone Injection to indicate that it is to be diluted to appropriate strength with water or other suitable fluid prior to administration.
Identification— Transfer a volume of Injection, equivalent to about 2 mg of mitoxantrone, to a 200-mL volumetric flask, add 100 mL of water and 20 mL of 1 N hydrochloric acid, dilute with water to volume, and mix: the UV absorption spectrum of this solution exhibits maxima and minima at the same wavelengths as that of a similar solution of USP Mitoxantrone Hydrochloride RS.
Bacterial endotoxins 85 It contains not more than 5 Endotoxin Units per mg of mitoxantrone.
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 each container being used.
pH 791: between 3.0 and 4.5.
Chromatographic purity— Using the chromatogram of the Assay preparation obtained as directed in the Assay, calculate the percentage of each impurity in the Injection taken by the formula:
100(ri / rS)
in which ri is the response of any individual peak, other than the main mitoxantrone peak; and rS is the sum of the responses of all the peaks in the chromatogram, including that of the main mitoxantrone peak: not more than 1.5% of any individual impurity and not more than 3.0% of the total impurities is found.
Other requirements— It meets the requirements under Injections 1.
Assay—
Sodium 1-heptanesulfonate solution, Mobile phase, System suitability solution, and Chromatographic system— Proceed as directed in the Assay under Mitoxantrone Hydrochloride.
Standard preparation— Transfer about 23 mg of USP Mitoxantrone Hydrochloride RS, accurately weighed, to a 50-mL volumetric flask, add 40 mL of Mobile phase, and dissolve by sonicating for about 5 minutes. Cool to room temperature, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 0.4 mg of mitoxantrone (C22H28N4O6) per mL.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 4 mg of mitoxantrone (C22H28N4O6), to a 10-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Mitoxantrone Hydrochloride. Calculate the quantity, in mg, of mitoxantrone (C22H28N4O6) in each mL of the Injection taken by the formula:
(444.49 / 517.40)(10C / V)(rU / rS)
in which 444.49 and 517.40 are the molecular weights of mitoxantrone and mitoxantrone hydrochloride, respectively; V is the volume, in mL, of the portion of Injection taken; and the other terms are as defined therein.
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Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
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(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2995
Pharmacopeial Forum: Volume No. 32(2) Page 355
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.