Mitoxantrone Injection
»Mitoxantrone Injection is a sterile solution of Mitoxantrone Hydrochloride in Water for Injection.It contains the equivalent of not less than 90.0percent and not more than 105.0percent of the labeled amount of mitoxantrone (C22H28N4O6).
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.
USP Reference standards á11ñ— USP Mitoxantrone Hydrochloride RS.USP Mitoxantrone System Suitability Mixture RS.
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.
Bacterial endotoxins á85ñ— It contains not more than 5Endotoxin Units per mg of mitoxantrone.
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.
pHá791ñ: between 3.0and 4.5.
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.
Other requirements— It meets the requirements under Injections á1ñ.
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 (C22H28N4O6)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 (C22H28N4O6)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.
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Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1304
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