Indocyanine Green for Injection
» Indocyanine Green for Injection contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C43H47N2NaO6S2.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 7.1 USP Endotoxin Units per mg of indocyanine green.
pH 791: between 5.5 and 7.5, in a solution (1 in 200).
Content variation— Transfer the contents of each of 5 containers individually to separate 100-mL volumetric 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 2.5 µg per mL. Proceed as directed in the Assay under Indocyanine Green, beginning with “Concomitantly determine the absorbances.” The requirements are met if the content of each of not less than 4 of the containers tested is within the limits specified under Uniformity of Dosage Units 905.
Other requirements— It responds to the Identification tests, and meets the requirements for Arsenic, Lead, Sodium iodide, and Assay under Indocyanine Green. It meets also the requirements for Sterility Tests 71 and for Labeling under Injections 1.
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
(RMI05) Radiopharmaceuticals and Medical Imaging Agents 05
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2632