ANYL 52 |
| Hydrazine is a widely used reagent in chemical syntheses of active pharmaceutical ingredients. However, hydrazine can introduce a substantial health hazard even at low concentrations, since it is a known carcinogen. According to current regulatory guidance, it is assumed that genotoxic compounds have the potential to damage DNA at any level of exposure. Thus, actual and potential impurities most likely to arise during synthesis, purification, and storage should be identified. Both the EMEA guidelines and a PhRMA white paper propose a limit of 1.5 µg/day for genotoxic impurities in pharmaceuticals. Such limits provide a significant challenge from an analytical perspective, since they require detection limits at low ppm-levels in the presence of a matrix that is very often problematic. In this poster a fast and sensitive method for the quantitation of hydrazine in pharmaceutical samples is demonstrated. |
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General Posters
7:00 PM-9:00 PM, Sunday, August 19, 2007 BCEC -- Exhibit Hall - B2, Poster
Division of Analytical Chemistry |