1
H-Benz[
e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2
H-benz[
e]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt.
2-[7-[1,1-Dimethyl-3-(4-sulfobutyl)benz[
e]indolin-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-1
Hbenz[
e]indolium hydroxide, inner salt, sodium salt
[
3599-32-4].
Packaging and storage—
Preserve in well-closed containers. Store at 25
, excursions permitted between 15
and 30
.
Labeling—
Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
Identification—
B:
To a solution (1 in 20,000) add 10 drops of 1 N sodium hydroxide, and heat to about 60
. Add 10 drops of
hydrogen peroxide TS, and mix: a red color develops within about 4 minutes and, on standing, fades to a pale orange.
Loss on drying 
731
—
Dry it in vacuum at 50
for 3 hours: it loses not more than 6.0% of its weight.
Lead—
A 5-mL portion of the solution prepared for the test for
Arsenic 211 contains not more than 2 µg of lead (corresponding to not more than 0.001%) when tested by the limit test for
Lead 251, 3 mL of
Ammonium Citrate Solution, 1 mL of
Potassium Cyanide Solution, and 0.5 mL of
Hydroxylamine Hydrochloride Solution being used.
Sodium iodide—
Dissolve about 200 mg, accurately weighed, in 100 mL of water, add 1 mL of nitric acid, mix, and titrate with 0.01 N silver nitrate VS, determining the endpoint potentiometrically, using silver and glass electrodes. Each mL of 0.01 N silver nitrate is equivalent to 1.499 mg of sodium iodide. Not more than 5.0% of sodium iodide, calculated on the dried basis, is found.
Other requirements—
Where the label states that Indocyanine Green is sterile, it meets the requirements for
Sterility Tests 71 and for
Bacterial endotoxins under
Indocyanine Green for Injection. Where the label states that Indocyanine Green must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for
Bacterial endotoxins under
Indocyanine Green for Injection.
Assay—
Dissolve a quantity of Indocyanine Green, equivalent to about 100 mg of dried indocyanine green and accurately weighed, in methanol, and dilute quantitatively and stepwise with methanol to obtain a solution containing about 2 µg per mL. Dissolve a quantity of
USP Indocyanine Green RS, accurately weighed, in methanol, and dilute quantitatively and stepwise with methanol to obtain a Standard solution having a known concentration of about 2 µg per mL. Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 785 nm, with a suitable spectrophotometer, using methanol as the blank. Calculate the quantity, in mg, of C
43H
47N
2NaO
6S
2 in the Indocyanine Green taken by the formula:
50C(AU / AS),
in which
C is the concentration, in µg per mL, of
USP Indocyanine Green RS in the Standard solution; and
AU and
AS are the absorbances of the solution of Indocyanine Green and the Standard solution, respectively.
Auxiliary Information—
Staff Liaison :
Radhakrishna S Tirumalai, Scientist
Expert Committee : (GTMDB05) General Toxicology and Medical Device Biocompatibility
USP29–NF24 Page 1124
Pharmacopeial Forum : Volume No. 29(6) Page 1905
Phone Number : 1-301-816-8339
;)