U.S. PHARMACOPEIA

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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.
Identification— It responds to Identification tests B, C, and D under Indigotindisulfonate Sodium.
Bacterial endotoxins 85— It contains not more than 5.0 USP Endotoxin Units per mg of indigotindisulfonate sodium.
pH 791: between 3.0 and 6.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
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 is the concentration, in µg per mL, of USP Indigotindisulfonate Sodium RS in the Standard solution; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the solution from the Injection and the Standard solution, respectively.
Auxiliary Information— Staff Liaison : Radhakrishna S Tirumalai, Scientist
Expert Committee : (GTMDB05) General Toxicology and Medical Device Biocompatibility
USP29–NF24 Page 1117
Phone Number : 1-301-816-8339