Packaging and storage—
Preserve in single-dose containers,preferably of Type Iglass.
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 2mg of mitoxantrone,to a 200-mLvolumetric flask,add 100mLof water and 20mLof 1Nhydrochloric acid,dilute with water to volume,and mix:the UVabsorption spectrum of this solution exhibits maxima and minima at the same wavelengths as that of a similar solution of
USP Mitoxantrone Hydrochloride RS.
Sterility á71ñ—
It meets the requirements when tested as directed for
Membrane Filtrationunder
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 preparationobtained as directed in the
Assay,calculate the percentage of each impurity in the Injection taken by the formula:
100(ri/rS),
in which
riis the response of any individual peak,other than the main mitoxantrone peak;and
rSis 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.
Assay—
Sodium 1-heptanesulfonate solution,Mobile phase,Resolution solution,and Chromatographic system—
Proceed as directed in the
Assayunder
Mitoxantrone Hydrochloride.
Standard preparation—
Transfer about 23mg of
USP Mitoxantrone Hydrochloride RS,accurately weighed,to a 50-mLvolumetric flask,add 40mLof
Mobile phase,and dissolve by sonicating for about 5minutes.Cool to room temperature,dilute with
Mobile phaseto volume,and mix.This solution contains the equivalent of about 0.4mg of mitoxantrone (C
22H
28N
4O
6)per mL.
Assay preparation—
Transfer an accurately measured volume of Injection,equivalent to about 4mg of mitoxantrone (C22H28N4O6),to a 10-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure—
Proceed as directed for
Procedurein the
Assayunder
Mitoxantrone Hydrochloride.Calculate the quantity,in mg,of mitoxantrone (C
22H
28N
4O
6)in each mLof the Injection taken by the formula:
(444.49/517.40)(10C/V)(rU/rS),
in which 444.49and 517.40are the molecular weights of mitoxantrone and mitoxantrone hydrochloride,respectively;
Vis the volume,in mL,of the portion of Injection taken;and the other terms are as defined therein.