Assessment of Proposed Cyclohexanone Limits for Containers

A limit of 5 mg was recently proposed as the European Pharmacopoeia limit for residual cyclohexanone in plastic containers for parenteral medical use with a nominal volume greater than 250 ml. Comparison of the proposed limit to published toxicological end-points and current governmental regulations...

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Bibliographic Details
Published inInternational journal of toxicology Vol. 18; no. 2; pp. 157 - 158
Main Authors Cammack, Jon N., White, Randy D., Wilson, Daniel M., Gonder, Janet C., Hoet, Patrick
Format Journal Article
LanguageEnglish
Published Los Angeles, CA SAGE Publications 01.03.1999
Taylor & Francis
Subjects
Biological and medical sciences
Chemical and industrial products toxicology. Toxic occupational diseases
Medical sciences
Solvents
Toxicology
Europe
Cyclohexanone
Containers
Residual Limit
Human
Limit dose
Toxicity
Animal
Legislation
Packaging
Dosage form
Pharmaceutical industry
Solvent
Parenteral administration
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Summary:A limit of 5 mg was recently proposed as the European Pharmacopoeia limit for residual cyclohexanone in plastic containers for parenteral medical use with a nominal volume greater than 250 ml. Comparison of the proposed limit to published toxicological end-points and current governmental regulations was used to assess the potential risk following exposure. Based on the comparison, no adverse effects would be predicted from clinical exposures to 5 mg residual cyclohexanone in containers with a nominal volume of greater than 250 ml.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
ISSN:1091-5818
1092-874X
DOI:10.1080/109158199225729