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 95.0 percent and not more than 110.0 percent of the labeled amount of C11H8Na4O8P2·6H2O.
Packaging and storage Preserve in single-dose, light-resistant containers, preferably of Type I glass.
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.
Bacterial endotoxins 85 It contains not more than 25.0 USP Endotoxin Units per mg of menadiol sodium diphosphate.
pH 791: between 7.5 and 8.5.
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.
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USP32NF27 Page 2876