Riboflavin Injection
»Riboflavin Injection is a sterile solution of Riboflavin in Water for Injection.It contains not less than 95.0percent and not more than 120.0percent of the labeled amount of C17H20N4O6.It may contain niacinamide or other suitable solubilizers.
Packaging and storage— Preserve in light-resistant,in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification— It responds to the Identificationtest under Riboflavin.
Bacterial endotoxins á85ñ— It contains not more than 7.1USP Endotoxin Units per mg of riboflavin.
pHá791ñ: between 4.5and 7.0.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Dilute an accurately measured volume of not less than 1mLof Injection to make a solution containing approximately 0.1µg of riboflavin per mL.Using this as the Assay Preparation,proceed as directed under Riboflavin Assay á481ñ.Calculate the quantity,in mg,of C17H20N4O6in each mLof the Injection taken by the formula:
C(A/B),
in which Cis the concentration,in mg per mL,of C17H20N4O6obtained for the Assay Preparation,Ais the test specimen dilution volume,in mL,and Bis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1723
Phone Number:1-301-816-8389