Acceptance criteria for levels of hydrazine in substances for pharmaceutical use and analytical methods for its determination.
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.
Kean
T
T
University of Strathclyde, Glasgow, UK.
Miller
J H McB
JH
Skellern
G G
GG
Snodin
D
D
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
D006834:Hydrazines; D004364:Pharmaceutical Preparations; C029424:hydrazine