[药品塑料容器JP标准提案]。

A Nakamura
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引用次数: 0

摘要

日本药典(JP)提出了一种新的药品塑料容器标准化方法,其结构分为以下三个部分:(1)一般信息部分中的“药品塑料容器”,描述了一般要求和合格的基本原理;(2) 通用测试部分中的“塑料容器的测试方法”描述了适用于验证合格性的各种测试方法;(3)专论部分对特殊容器(如输液袋)的特殊要求和/或极限值。新标准的设计应涵盖任何形状和体积的塑料容器,由任何种类的材料制成。
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[Proposal of JP standards for plastic containers for pharmaceuticals].

A new approach to standardization of plastic containers for pharmaceuticals in the Pharmacopoeia of Japan (JP) has been proposed, structured into the following three parts: (1) "Plastic Containers for Pharmaceuticals" in the GENERAL INFORMATION section that describes the general requirements and rationales for conformity; (2) "Test Methods for Plastic Containers" in the GENERAL TESTS section that describes various test methods applicable for verifying conformity; (3) Special requirements and/or limit values for special containers such as infusion bags in a MONOGRAPH section. New standards should be designed to cover plastic containers of any shape and volume made of any kind of material.

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