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可提取物和可浸出物可提取物和可浸出物:: 注射制剂（注射制剂（ LLVPVP ）的最佳实践）的最佳实践 Forum of Infusion Packaging Development Qingdao, China 6 September 2012 中国输液包装发展论坛 20 12年9月6 日 Edward J. Smith, Ph.D. 2012 by Packaging Science Resources, LLC, King of Prussia, PA (USA). All rights reserved. This material is protected by copyright. No part of it Packaging Science Resources, LLC may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying or otherwise, without written permission of Packaging Science Resources, LLC. PDF 文件使用 pdfFactory Pro 试用版本创建 Disclaimer 声明 n The content of this presentation represents the opinions of Edward J. Smith and Packaging Science Resources, LLC alone and not necessarily those of the PRQI, PDA, or any other organization with which he is affiliated. n 本报告中的观点仅代表我个人和公司。不代表我加入的 PRQI、PDA以及其它协会。 2 Copyright 2012 Packaging Science Resources, LLC PDF 文件使用 pdfFactory Pro 试用版本创建 Presentation Outline报告提纲 I. Best Extractables and Leachables (EL) Practices for Large Volume Parenterals (LVPs)大容量输液（LVPs）的可提取物和浸出物 （EL)的最佳实践 - Guidance from the Pharmaceutical Quality Research Institute (PQRI)药品质量研究所的指导原则 II. The Role of EL Studies in Demonstrating CompatibilityEL研究在 相容性研究中的作用 III. EL Details可提取物和 浸出物细节 a. Relationship between Extractables and Additives可提取物和添加剂的关系 b. Validation of Methods for EL Te