Application Note

Extractables Analysis
An ideal filtration device is non-interactive. It does not adsorb or remove ingredients from a drug product, nor does it impart extractables into it. It is important to test the filtration device for its compatibility, retention characteristics, non-interaction and safety under minimum and maximum operating conditions. Drug products and filter components are typically organic in nature. Because most drugs contain a much greater concentration of organic material as compared to filters, it is often impossible to develop a practical analytical method to accurately detect and quantitate extractables. Therefore, even the most precise analytical equipment employing the most accurate methods may not be able to detect filter extractables when using actual drug product. However, each application is evaluated on a case by

case basis. No single analytical method can provide reliable extractables information for all filters. The specific model solvent streams tested and the specific analytical methodologies employed are specific to a filtration device. Appropriate solvent streams are selected. Test protocols are developed, and analysis is performed. Detailed information about your process fluids or specific drug product and how it is processed using Millipore filtration device(s) is needed to address your specific extractables testing needs.

The Millipore Advantage

Millipores analytical and chromatography expertise was used to successfully develop Millipores approach to extractables analysis. Our extensive knowledge of filtration technology and continued research has allowed us to provide technical expertise to our customers.

Approach/Procedure
Millipore proposes a rational systematic approach that simulates the worst-case conditions for a filtration device. This approach detects and quantitates extractables, and is generic so it can be applied to any filtration device.

How to Request Extractables Analysis

A Millipore Validation Specialist can provide you with the technical expertise needed to conduct extractables analysis. To request extractables documentation or to get information on other validation services provided by Millipore, call your Millipore Applications Specialist or the Millipore office closest to you.

 Use model stream test approach  Perform trials under worst-case conditions  Bases analytical method on filter materials of

construction and model solvent stream

 Tests performed by qualified experts  Verify compatible filtration materials

The Validation Sciences Laboratory at Millipore is only

one of many quality programs in place that ensure Millipore products meet the high standards of the pharmaceutical industry. Prior to product release, final lot release tests ensure released filters will meet Millipores strict control parameters. Millipore produces validation guides for pharmaceutical-grade filters that contain complete extractables data.

Ordering Information
Contact your local Validation Sciences Laboratory for a current request form. The scope of your project will be determined by the request and process conditions. A catalog number will be assigned accordingly. To request extractables analysis or to get information on other validation services, call your Millipore Applications Specialist or the Millipore office nearest you. In the U.S. and Canada, call toll-free 1-800-MILLIPORE (1-800-645-5476) In Europe call: +33 (0) 390 469898

www.millipore.com/offices
Millipore and Access are registered trademarks of Millipore Corporation. The M mark and Advancing Life Science Together are trademarks of Millipore Corporation. Lit. No. VB007 Rev. B Printed in U.S.A. 12/08 BP-GEN-08-01224 2008 Millipore Corporation, Billerica, MA 01821 U.S.A. All rights reserved.