» Riboflavin Injection is a sterile solution of Riboflavin in Water for Injection. It contains not less than 95.0 percent and not more than 120.0 percent 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 I glass.
Bacterial endotoxins 85 It contains not more than 7.1 USP Endotoxin Units per mg of riboflavin.
pH 791: between 4.5 and 7.0.
Other requirements It meets the requirements under Injections 1.
Assay Dilute an accurately measured volume of not less than 1 mL of Injection to make a solution containing approximately 0.1 µg of riboflavin per mL. Using this as the Assay Preparation, proceed as directed under Riboflavin Assay 481. Calculate the quantity, in mg, of C17H20N4O6 in each mL of the Injection taken by the formula:
C(A / B)in which C is the concentration, in mg per mL, of C17H20N4O6 obtained for the Assay Preparation, A is the test specimen dilution volume, in mL, and B is the volume, in mL, of Injection taken.
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USP32NF27 Page 3498