Pharmeur Sci Notes. 2006 Dec;2006(2):23-33.

Acceptance criteria for levels of hydrazine in substances for pharmaceutical use and analytical methods for its determination.

Kean T, Miller JH, Skellern GG, Snodin D.

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University of Strathclyde, Glasgow, UK.

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.

PMID:: 17691211; [PubMed - indexed for MEDLINE]

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Acceptance criteria for levels of hydrazine in substances for pharmaceutical use and analytical methods for its determination.

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