Indigotindisulfonate Sodium Injection
»Indigotindisulfonate Sodium Injection is a sterile solution of Indigotindisulfonate Sodium in Water for Injection.It contains not less than 90.0percent and not more than 105.0percent of the labeled amount of C16H8N2Na2O8S2.
Packaging and storage— Preserve in single-dose,light-resistant containers,preferably of Type Iglass.
Identification— It responds to Identificationtests B,C,and Dunder Indigotindisulfonate Sodium.
Bacterial endotoxins á85ñ— It contains not more than 5.0USP Endotoxin Units per mg of indigotindisulfonate sodium.
pHá791ñ: between 3.0and 6.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Quantitatively dilute a portion of Injection,equivalent to about 40mg of indigotindisulfonate sodium,with dilute hydrochloric acid (1in 100)to obtain a solution having a known concentration of about 10µg of indigotindisulfonate sodium per mL.Proceed as directed in the Assayunder Indigotindisulfonate Sodium,beginning with “Concomitantly determine the absorbances.”Calculate the quantity,in mg,of C16H8N2Na2O8S2in each mLof the Injection taken by the formula:
4(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Indigotindisulfonate Sodium RSin the Standard solution,Vis the volume,in mL,of Injection taken,and AUand ASare the absorbances of the solution from the Injection and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(GTB)General Toxicology and Biocompatibility
USP28–NF23Page 1008
Phone Number:1-301-816-8339