Packaging and storage—
Preserve in single-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.
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.
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 (C
22H
28N
4O
6) 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 (C
22H
28N
4O
6) 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.
