Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.

USP Reference standards 11— USP Endotoxin RS. USP Indocyanine Green RS.

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.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (GTMDB05) General Toxicology and Medical Device Biocompatibility

USP29–NF24 Page 1124

Phone Number : 1-301-816-8339