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Research ArticleRESEARCH

Determination of “Extractables” on Polymer Materials by Means of HPLC-MS

S. Fichtner, U. Giese, I. Pahl and O.W. Reif
PDA Journal of Pharmaceutical Science and Technology September 2006, 60 (5) 291-301;
S. Fichtner
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U. Giese
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I. Pahl
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O.W. Reif
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  • For correspondence: oscar.reif@sartorius.com
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Abstract

In biopharmaceutical processes, in the area of food and medical technology a variety of devices is used. These devices consist of various polymers. The detection and identification of potential extractables from these polymers during application are requested by the regulatory bodies. For risk and toxicity assessment, both identification and quantification of extractables are necessary. This article describes the development of a LS—MS methodology transfered from an established HPLC—UV—VIS method for full extractables analysis of sterile-grade filtration cartridges.

  • LC-MS
  • Polymer
  • Extractables

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  • Copyright © Parenteral Drug Association. All rights reserved.
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PDA Journal of Pharmaceutical Science and Technology
Vol. 60, Issue 5
September/October 2006
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Determination of “Extractables” on Polymer Materials by Means of HPLC-MS
S. Fichtner, U. Giese, I. Pahl, O.W. Reif
PDA Journal of Pharmaceutical Science and Technology Sep 2006, 60 (5) 291-301;
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Determination of “Extractables” on Polymer Materials by Means of HPLC-MS
S. Fichtner, U. Giese, I. Pahl, O.W. Reif
PDA Journal of Pharmaceutical Science and Technology Sep 2006, 60 (5) 291-301;

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