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.
Bacterial endotoxins 
85
—
It contains not more than 5.0 USP Endotoxin Units per mg of indigotindisulfonate sodium.
85—
It contains not more than 5.0 USP Endotoxin Units per mg of indigotindisulfonate sodium.
pH 791:
between 3.0 and 6.5.
791:
between 3.0 and 6.5.
Other requirements—
It meets the requirements under Injections 1.
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—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals 1-301-816-8178 |
(RMI05) Radiopharmaceuticals and Medical Imaging Agents 05 |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 2625