Indocyanine Green
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1H-Benz[e]indolium,2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-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)-1Hbenz[e]indolium hydroxide,inner salt,sodium salt [3599-32-4].
»Indocyanine Green contains not less than 94.0percent and not more than 105.0percent of C43H47N2NaO6S2,calculated on the dried basis.It contains not more than 5.0percent of sodium iodide,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 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—
A:
Incinerate a portion of it:the residue responds to the tests for Sodium á191ñand for Sulfate á191ñ.
B:
To a solution (1in 20,000)add 10drops of 1Nsodium hydroxide,and heat to about 60.Add 10drops of hydrogen peroxide TS,and mix:a red color develops within about 4minutes and,on standing,fades to a pale orange.
.Add 10drops of hydrogen peroxide TS,and mix:a red color develops within about 4minutes and,on standing,fades to a pale orange.
Loss on drying á731ñ—
Dry it in vacuum at 50for 3hours:it loses not more than 6.0%of its weight.
for 3hours:it loses not more than 6.0%of its weight.
Arsenic,Method IIá211ñ:
8ppm.
Lead—
A5-mLportion of the solution prepared for the test for Arsenic á211ñcontains not more than 2µg of lead (corresponding to not more than 0.001%)when tested by the limit test for Lead á251ñ,3mLof Ammonium Citrate Solution,1mLof Potassium Cyanide Solution,and 0.5mLof Hydroxylamine Hydrochloride Solutionbeing used.
Sodium iodide—
Dissolve about 200mg,accurately weighed,in 100mLof water,add 1mLof nitric acid,mix,and titrate with 0.01Nsilver nitrate VS,determining the endpoint potentiometrically,using silver and glass electrodes.Each mLof 0.01Nsilver nitrate is equivalent to 1.499mg 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 á71ñand for Bacterial endotoxinsunder 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 endotoxinsunder Indocyanine Green for Injection.
Assay—
Dissolve a quantity of Indocyanine Green,equivalent to about 100mg of dried indocyanine green and accurately weighed,in methanol,and dilute quantitatively and stepwise with methanol to obtain a solution containing about 2µg 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 2µg per mL.Concomitantly determine the absorbances of both solutions in 1-cm cells at the wavelength of maximum absorbance at about 785nm,with a suitable spectrophotometer,using methanol as the blank.Calculate the quantity,in mg,of C43H47N2NaO6S2in the Indocyanine Green taken by the formula:
50C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Indocyanine Green RSin the Standard solution;and AUand ASare the absorbances of the solution of Indocyanine Green and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(GTB)General Toxicology and Biocompatibility
USP28–NF23Page 1012
Pharmacopeial Forum:Volume No.29(6)Page 1905
Phone Number:1-301-816-8339