Packaging and storage—
Preserve in single-dose, light-resistant containers, preferably of Type I glass.
Identification—
A:
Transfer a volume of Injection, equivalent to about 100 mg of menadiol sodium diphosphate, to a separator, add 10 mL of 2 N sulfuric acid, and extract with six 25-mL portions of ether, discarding the ether extracts. To the aqueous solution add 1 mL of 0.5 N ceric sulfate and 1 mL of 30 percent hydrogen peroxide, and extract with two 10-mL portions of chloroform. Evaporate the combined chloroform extracts on a steam bath just to dryness, then dry at 80
for 1 hour: the IR absorption 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 test B under
Menadiol Sodium Diphosphate.
B:
Adjust, if necessary, a volume of Injection, equivalent to about 20 mg of menadiol sodium diphosphate, by evaporation or dilution with water, as required, to 2 mL: the solution responds to
Identification test C under
Menadiol Sodium Diphosphate.
Other requirements—
It meets the requirements under
Injections 
1
.
Assay—
Transfer an accurately measured volume of Injection, equivalent to about 50 mg of menadiol sodium diphosphate, to a 125-mL separator, and extract with three 25-mL portions of chloroform, discarding the chloroform extracts. Transfer the aqueous solution to a 250-mL beaker, add 25 mL of glacial acetic acid and 25 mL of 3 N hydrochloric acid, vigorously bubble nitrogen through this solution for not less than 15 minutes, and titrate with 0.01 N ceric sulfate VS, determining the endpoint potentiometrically using a calomel-platinum electrode system. Each mL of 0.01 N ceric sulfate is equivalent to 2.651 mg of C11H8Na4O8P2·6H2O.
