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Draft USP Chapter <671> Containers - Performance Testing USP<671>容器—性能测试草案 A revised version of generalchapter <671> Containers—Performance Testing has been published inPharmacopeial Forum 43(1) [Jan.-Feb. 2017]. Comments will be accepted untilMarch 31, 2017, the end of the comment period for Pharmacopeial Forum (PF)43(1). 修订后的通论<671>容器---性能测试已在药典论坛43(1)【2017年1-2月】上发布。公开征求意见截止日期为2017年3月31日。 On the basis of commentsreceived, the General Chapters—Packaging and Storage Expert Committee isproposing the following changes: 在所收到的意见的基础上，通论---包装和存贮专家委员会提交了以下修订：
Additionally, minor editorialchanges have been made to update the chapter to current USP style. 此外，还做了一些小的编辑性修订以适应现在的USP形式。 The following chaptersreference the general chapter <671> under revision and need to bereviewed to keep references to <671> accurate: 以下章节引用了<671>，因此需要进行审核以保证<671>的准确性：
Other monographs and/orchapters may also be listed, even where the reference to <671> remainsunchanged, as additional notice to stakeholders where there is believed to bepotential for the change in <671> itself to affect pass-faildeterminations for particular monograph articles. 可能还列出了一些其它各论和/或章节，即使这些引用<671>并没有修改，作为对相关方的通知，因为<671>本身的一些修订可能会影响各论检测的结果是否通过。 It is the purpose of thischapter to provide standards for the functional properties of packaging systemsused for solid oral dosage forms (SODF) and liquid oral dosage forms (LODF).The tests that follow are provided to determine the moisture vapor transmissionrate (water vapor permeation rate) for plastic packaging systems formanufacturers, packagers, and repackagers. This chapter also includes aclassification system for plastic packaging systems that allowspharmacists and institutional repackagers to select appropriate containers torepackage SODFs and LODFs. Definitions that apply to this classification systemare provided in Packaging and Storage Requirements <659>. 该章节的目的是为固体口服制剂（SODF）和液体口服制剂（LODF）所用的包装系统的功能属性提供标准。主要为生产商、包装商和重新包装商提供方法来确定塑料包装系统的水汽透过率（水汽穿透率）。本章也包括一个塑料包装系统分类体系，让执业药师和重新包装机构可以选择适当的容器来重新包装SODF和LODF。在包装和存贮要求<659>中还提供了此分类体系适用的定义。 The revised chapter isstructured as follows: 修订后的章节结构如下： INTRODUCTION 概述 塑料包装系统水汽透过性 ― 介绍 ― 口服剂型包装系统干燥剂方法 塑料包装系统分类体系 ― 介绍 ― 固体口服剂型和液体剂型包装系统 ― 液体口服剂包装系统 术语 The classification systemincludes methods that allow pharmacists and institutional repackagers to selectappropriate containers for repackaging of SODFs and LODFs. The classificationsystem provided can also be used by the drug product manufacturer for testingpackaging systems that have had the primary seal broached. 分类体系包括执业药师和重新包装机构用来选择适当容器用于SODF和LODF重新包装的方法。分类体系也可以用于药品生产商测试内包密封钻孔的包装系统。 Recently, the omission of the 'well-closed' specificationfrom <671> has been proposed. However, the method for measuring the permeationof water vapor in multiple-unit containers for SODF in section CLASSIFICATIONSYSTEM FOR PLASTIC PACKAGING SYSTEMS of the current draft still provides twoacceptance criteria for containers, defined as “tight” and “well-closed”. 最近，有人提出要忽略<671>“密闭良好的”质量标准。但是，现在草案中在塑料包装系统分类体系中测量SODF多剂量容器水汽透过性还是有两个可接受容器标准，定义为“紧闭”和“密闭良好”。 Following your registration onthe USP website you can get to the completedraft of <671> Containers—Performance Testing. 在USP网站上注册后就能获得完整的<671>草案。 |
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