Ethanaminium, N-[4-[[4-(diethylamino)phenyl](2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, hydroxide, inner salt, sodium salt;
Sodium 5-{[4-(diethylamino)phenyl][4-(diethyliminio)cyclohexa-2,5-dien-1-ylidene]methyl}benzene-1,4-disulfonate [68238-36-8]
BRIEFING
Isosulfan Blue. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed.
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The proposed liquid chromatographic procedure in the Assay was validated with the Venusil XBP C18 (L) brand of column with L1 packing. The typical retention time for isosulfan blue is about 15 min.
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The proposed liquid chromatographic procedure in the test for Organic Impurities was validated with the Venusil XBP C18 (L) brand of column with L1 packing. The typical retention time for isosulfan blue is about 16 min.
Stakeholders are encouraged to submit a validated chemical identification method for the presence of sodium ion.
Description and solubility information: Dark bluish-green powder or granules. Soluble in water; sparingly soluble in ethanol.
(SM4: R. Nguyen)
Case ID—SUB-1037
USP REFERENCE STANDARDS FOR PURCHASE
USP Isosulfan Blue RSUSP Isosulfan System Suitability Mixture RS