Affordable Access

Interlaboratory comparison of analytical methods for residual ethylene oxide in medical device materials.

Authors
Type
Published Article
Journal
Journal of Pharmaceutical Sciences
0022-3549
Publisher
Elsevier
Publication Date
Volume
76
Issue
4
Pages
333–337
Identifiers
PMID: 3598894
Source
Medline

Abstract

An interlaboratory comparison of four gas chromatographic test procedures for the quantification of ethylene oxide in an acrylic polymer was conducted by thirteen laboratories. The procedures included extractions with water, acetone, and N,N-dimethylformamide, and headspace gas analysis. The results of this study, using only the data from the labs that did not deviate from the procedure, showed that the average estimated total coefficient of variation ranged from 8 to 22% for the four different methods. Each of the methods is suitable for use as a reference test method for determining residual ethylene oxide in polymeric materials.

There are no comments yet on this publication. Be the first to share your thoughts.

Statistics

Seen <100 times
0 Comments
F