Riboavin Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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» 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.

USP Reference standards 〈11〉—

USP Riboflavin RS

1 Identification—

It responds to the Identification test under Riboflavin.

Bacterial Endotoxins Test 〈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 and Implanted Drug Products 〈1〉.

2 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〉, Chemical Methods, Procedure 1.

Calculate the quantity, in mg, of C₁₇H₂₀N₄O₆ in each mL of the Injection taken by the formula:

C(A / B)

in which

C = concentration, in mg per mL, of C₁₇H₂₀N₄O₆ obtained for the Assay Preparation

A = test specimen dilution volume, in mL

B = volume, in mL, of Injection taken