Indigotindisulfonate Sodium 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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Indigotindisulfonate Sodium Injection

» Indigotindisulfonate Sodium Injection is a sterile solution of Indigotindisulfonate Sodium in Water for Injection. It contains not less than 90.0 percent and not more than 105.0 percent of the labeled amount of C₁₆H₈N₂Na₂O₈S₂.

Packaging and storage—

Preserve in single-dose, light-resistant containers, preferably of Type I glass.

USP Reference standards 〈11〉—

USP Indigotindisulfonate Sodium RS

1 Identification—

It responds to Identification tests B, C, and D under Indigotindisulfonate Sodium.

Bacterial Endotoxins Test 〈85〉—

It contains not more than 5.0 USP Endotoxin Units per mg of indigotindisulfonate sodium.

pH 〈791〉—

Between 3.0 and 6.5.

Other requirements—

It meets the requirements under Injections and Implanted Drug Products 〈1〉.

2 Assay—

Quantitatively dilute a portion of Injection, equivalent to about 40 mg of indigotindisulfonate sodium, with dilute hydrochloric acid (1 in 100) to obtain a solution having a known concentration of about 10 µg of indigotindisulfonate sodium per mL.

Proceed as directed in the Assay under Indigotindisulfonate Sodium, beginning with “Concomitantly determine the absorbances.”

Calculate the quantity, in mg, of C₁₆H₈N₂Na₂O₈S₂ in each mL of the Injection taken by the formula:

4(C/V)(Aᵤ/Aₛ)

in which:

C = concentration, in µg per mL, of USP Indigotindisulfonate Sodium RS in the Standard solution

V = volume, in mL, of Injection taken

Aᵤ = absorbance of the solution from the Injection

Aₛ = absorbance of the Standard solution