塑料包装材料USP要求更新

20150429 ECA新闻：塑料包装材料USP要求更新  

2015-04-2923:52:55|  分类： ECA新闻

GMP News
29/04/2015

Update of the USP Requirements for Packaging Materialsmade of Plastics

塑料包装材料USP要求更新

In the Pharmacopoeial Forum 40(5) the USP publishedseveral proposals on the revision of the General Chapters on packagingmaterials made of plastics.

在药典论坛能0（5）中，USP公布了几个修订塑料包材通论的提议。

In the future, the following general chapters areplanned:

在将来，计划制订以下通论：

• Plastic packaging systems and theirmaterial of construction < 661 >
• 塑料包装系统和其结构材料<661>
• Plastic material of construction <661.1 >
• 结构中的塑料材料<661.1>
• Plastic packaging systems forpharmaceutical use < 661.2 >
• 药用塑料包装系统<661.2>
• Evaluation of plastic packaging systemsand their material of construction with respect to their user safety impact< 1661 >
• 对塑料包装系统的评估，以及其结构对其使用者的安全影响<1661>
  Packaging materials made of plastic are comprised ofhomologous polymers with different molecular weights and contain additives suchas antioxidants, plasticizers, pigments and other components.
  塑料包材是不同分子量相似的聚合物组成的，含有一些添加剂，如抗氧剂、塑化剂、色素和其它成分。
  The General Chapter of < 661.1 > will cover thetests which demonstrate that a material can be viewed as well characterized.These include:
  通论<661.1>将包括一些测试，证明一个物料是很好定性的。它们包括：
  
  

• Identity  
• 鉴别
• Biocompatibility (Biologicalreactivity)
• 生物相容性（生物反应性）
• General physicochemical properties
• 常规理化特性
• Additives
• 添加剂
• Extractable metals  
• 可萃出金属
  For all further information on the General chapters inthe revision process, please see the USP Website of the Pharmacopeial Forum (PF).
  更多修订中通论的信息，参见上述网址。
  
  

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015329115255145/