Acceptance criteria for levels of hydrazine in substances for pharmaceutical use and analytical methods for its determination
Autor: | Thomas Kean, Jh, Miller, Gg, Skellern, Snodin D |
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Rok vydání: | 2007 |
Předmět: |
Pharmacopoeias as Topic
Quality Control No-Observed-Adverse-Effect Level Reproducibility of Results Pilot Projects Chromatography Ion Exchange Europe Hydrazines Pharmaceutical Preparations Toxicity Tests Animals Humans Technology Pharmaceutical Chromatography Thin Layer Drug Contamination Chromatography High Pressure Liquid |
Zdroj: | Europe PubMed Central |
ISSN: | 1814-2435 |
Popis: | This report includes a brief review of the toxicology of hydrazine and the strategies used to set acceptance criteria. A preliminary examination of a number of approaches to determine hydrazine in pharmaceutical substances susceptible to its presence either as residue from the synthesis or from decomposition are described. |
Databáze: | OpenAIRE |
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