2
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found

      Endotoxin Level of Sterile Injection Solutions and Substitution Fluid for Hemofiltration in Japan and Australia

      Read this article at

      ScienceOpenPublisherPubMed
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          The endotoxin contamination levels of sterile distilled water and saline solutions used for injection and hemofiltration in Japan and Australia were examined with a colorimetric limulus test using a chromogenic substrate. The endotoxin levels of injection solutions in most products from both countries measured against E. coli 0111 :B4 endotoxin or USP reference standard endotoxin were less than 0.2 pg or 0.0006 endotoxin units (EU)·ml<sup>-1</sup>. Only 2 solutions in 30 from both countries showed higher levels: 7.7 and 10.8 pg for E. coli 0111 :B4 endotoxin ml<sup>-1</sup> (0.02 and 0.03 EU · ml<sup>-1</sup>). Even these higher values were well below the level recommended by the draft guideline published by the United States Food and Drug Administration (FDA). The endotoxin contamination level of a Japanese hemofiltration substitution fluid ranged from 8.2 to 9.2 pg E. coli 0111 :B4 endotoxin · ml<sup>-1</sup> (0.024–0.027 EU · ml<sup>-1</sup>).

          Related collections

          Author and article information

          Journal
          NEF
          Nephron
          10.1159/issn.1660-8151
          Nephron
          S. Karger AG
          1660-8151
          2235-3186
          1986
          1986
          04 December 2008
          : 42
          : 2
          : 128-132
          Affiliations
          aWater Research Institute, Nagoya University, Nagoya; bTokyo Research Institute, Seikagaku Kogyo Ltd., Tokyo; cInstitute of Environmental Science for Human Life, Ochanomizu University, Tokyo, Japan
          Article
          183651 Nephron 1986;42:128–132
          10.1159/000183651
          3511393
          © 1986 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

          Page count
          Pages: 5
          Categories
          Original Paper

          Comments

          Comment on this article