title: Acceptance criteria for levels of hydrazine in substances for pharmaceutical use and analytical methods for its determination.
abstract: 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.
authors: University of Strathclyde, Glasgow, UK.
authors: T
authors: T
authors: Kean
authors: J H McB
authors: JH
authors: Miller
authors: G G
authors: GG
authors: Skellern
authors: D
authors: D
authors: Snodin
mesh_terms: D000818:Animals; D002851:Chromatography, High Pressure Liquid; D002852:Chromatography, Ion Exchange; D002855:Chromatography, Thin Layer; D004340:Drug Contamination / Q000517:prevention & control*; D005060:Europe; D006801:Humans; D006834:Hydrazines / Q000032:analysis* / Q000633:toxicity; D019055:No-Observed-Adverse-Effect Level; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards; D010602:Pharmacopoeias as Topic; D010865:Pilot Projects; D011786:Quality Control; D015203:Reproducibility of Results; D013678:Technology, Pharmaceutical / Q000379:methods*; D018675:Toxicity Tests
chemical_list: D006834:Hydrazines; D004364:Pharmaceutical Preparations; C029424:hydrazine