Menadiol Sodium Diphosphate Injection
»Menadiol Sodium Diphosphate Injection is a sterile solution of Menadiol Sodium Diphosphate in Water for Injection.It contains not less than 95.0percent and not more than 110.0percent of the labeled amount of C11H8Na4O8P2·6H2O.
Packaging and storage—
Preserve in single-dose,light-resistant containers,preferably of Type Iglass.
Identification—
A:
Transfer a volume of Injection,equivalent to about 100mg of menadiol sodium diphosphate,to a separator,add 10mLof 2Nsulfuric acid,and extract with six 25-mLportions of ether,discarding the ether extracts.To the aqueous solution add 1mLof 0.5Nceric sulfate and 1mLof 30percent hydrogen peroxide,and extract with two 10-mLportions of chloroform.Evaporate the combined chloroform extracts on a steam bath just to dryness,then dry at 80
for 1hour:the IRabsorption spectrum of a potassium bromide dispersion of the menadione so obtained exhibits maxima at the same wavelengths as that of a similar preparation of USP Menadione RS.The solid also responds to Identification testBunder Menadiol Sodium Diphosphate.
for 1hour:the IRabsorption spectrum of a potassium bromide dispersion of the menadione so obtained exhibits maxima at the same wavelengths as that of a similar preparation of USP Menadione RS.The solid also responds to Identification testBunder Menadiol Sodium Diphosphate.
B:
Adjust,if necessary,a volume of Injection,equivalent to about 20mg of menadiol sodium diphosphate,by evaporation or dilution with water,as required,to 2mL:the solution responds to Identification testCunder Menadiol Sodium Diphosphate.
Bacterial endotoxins á85ñ—
It contains not more than 25.0USP Endotoxin Units per mg of menadiol sodium diphosphate.
pHá791ñ:
between 7.5and 8.5.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Transfer an accurately measured volume of Injection,equivalent to about 50mg of menadiol sodium diphosphate,to a 125-mLseparator,and extract with three 25-mLportions of chloroform,discarding the chloroform extracts.Transfer the aqueous solution to a 250-mLbeaker,add 25mLof glacial acetic acid and 25mLof 3Nhydrochloric acid,vigorously bubble nitrogen through this solution for not less than 15minutes,and titrate with 0.01Nceric sulfate VS,determining the endpoint potentiometrically using a calomel-platinum electrode system.Each mLof 0.01Nceric sulfate is equivalent to 2.651mg of C11H8Na4O8P2·6H2O.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(PA5)Pharmaceutical Analysis 5
USP28–NF23Page 1203
Phone Number:1-301-816-8305