Packaging and storage— Preserve in light-resistant, in single-dose or in multiple-dose containers, preferably of Type I glass.

USP Reference standards 11— USP Riboflavin RS. USP Endotoxin RS.

Identification— It responds to the Identification test under Riboflavin.

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.

Residual solvents 467: meets the requirements.

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: 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.

Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals

USP29–NF24 Page 1913

Phone Number : 1-301-816-8389