ANYL 174 |
| As part of a clinical study to study the potential of an exogenously supplied NO-donor to treat male erectile dysfunction, we required a formulation of sterilized S-nitrosoglutathione suitable for injection. After gamma-irradiation of the septum sealed vials of the compound, a new unidentified peak appeared by HPLC chromatography using ultraviolet detection at 210 nm. Efforts to identify the structure of the impurity showed it not to be glutathionsulfonic acid as reported to be produced from glutathione by x-ray irradiation, nor was it the sulfoxide of the oxidized glutathione. Surprisingly, it was found to be inorganic nitrate. The identification of nitrate was made by (1) the observation of the negative ion peak at 62 amu in the mass spectra, (2) identification by ion chromatography of the impurity as nitrate ion, and (3) co-elution of the impurity with sodium nitrate on reverse phase HPLC. Details regarding the identification of the impurity as nitrate and a proposed mechanism of how it was produced will be presented. |
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General Papers
7:00 PM-9:00 PM, Sunday, 28 August 2005 Washington DC Convention Center -- Hall A, Poster
Division of Analytical Chemistry |