Indocyanine Green for Injection
»Indocyanine Green for Injection contains not less than 90.0percent and not more than 110.0percent of the labeled amount of C43H47N2NaO6S2.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 7.1USP Endotoxin Units per mg of indocyanine green.
pHá791ñ: between 5.5and 7.5,in a solution (1in 200).
Content variation— Transfer the contents of each of 5containers individually to separate 100-mLvolumetric flasks with the aid of methanol.To each flask add methanol to volume.Dilute the solutions quantitatively and stepwise with methanol,to obtain a concentration of about 2.5µg per mL.Proceed as directed in the Assayunder Indocyanine Green,beginning with “Concomitantly determine the absorbances.”The requirements are met if the content of each of not less than 4of the containers tested is within the limits specified under Uniformity of Dosage Units á905ñ.
Other requirements— It responds to the Identificationtests,and meets the requirements for Arsenic,Lead,Sodium iodide,and Assayunder Indocyanine Green.It meets also the requirements for Sterility Tests á71ñand for Labelingunder Injections á1ñ.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(GTB)General Toxicology and Biocompatibility
USP28–NF23Page 1013
Phone Number:1-301-816-8339