Evaluating impurities in drugs--Part II
The genotoxins ethyl chloride, methyl chloride and isopropyl chloride were generated during the preparation of the hydrochloride salts of ethanol, methanol and isopropyl alcohol (ICH listed solvents) respectively at lower temperature (< 5 0C) as the key parameter of these impurities, in alcohol s...
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| Veröffentlicht in: | Pharmaceutical technology Europe 2012-03, Vol.24 (3), p.29 |
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| container_title | Pharmaceutical technology Europe |
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| creator | Wadekar, Kashyap R Bhalme, Mitali Rao, S. Srinivasa Reddy, K. Vigneshwar Kumar, L. Sampath Balasubrahmanyam, E Ravi, Ponnaiah |
| description | The genotoxins ethyl chloride, methyl chloride and isopropyl chloride were generated during the preparation of the hydrochloride salts of ethanol, methanol and isopropyl alcohol (ICH listed solvents) respectively at lower temperature (< 5 0C) as the key parameter of these impurities, in alcohol solvents, when HCl was 37% aqueous HCl or gas, it creates the maximum chance to form these alkyl fialide impurities at trace levels. These impurities are detectable in GC at ppm level. |
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| identifier | ISSN: 1753-7967 |
| ispartof | Pharmaceutical technology Europe, 2012-03, Vol.24 (3), p.29 |
| issn | 1753-7967 |
| language | eng |
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| source | Business Source Complete; EZB-FREE-00999 freely available EZB journals |
| subjects | Carcinogens Chirality Chromatography Contamination Drugs Genetic toxicology Manufacturing Measurement Metabolism Metabolites Molecules Nitrogen Pharmaceutical industry Pharmaceutical sciences Product quality Production processes Quality management Series & special reports |
| title | Evaluating impurities in drugs--Part II |
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