USP新提议的包装的水蒸汽通透性优化检测方法

ECA新闻20150603: USP新提议的包装的水蒸汽通透性优化检测方法  

GMP News
03/06/2015

Optimized Method for determining theWater Vapour Permeability for Packaging - new USP Proposal

USP新提议的包装的水蒸汽通透性优化检测方法

In thePharmacopeial Forum 41(1) a "stimulus to the revision process"article on pharmaceutical packaging has been published. This article proposes anew method for the determination of the permeability of water vapour for theGeneral Chapter <671>.

在药典论坛41（1）中，公布了一篇药物包装“促进修改过程”的章节。该章节提出了一种新的测定水蒸汽通性的方法包括在通论<671>中。

Thedetermination of the permeability rate for water vapour ("water vapourtransmission rate", WVTR) applies for solid dosage forms such as tabletsor capsules that are packed in plastic bottles or blister packs.

水蒸汽透过率（WVTR）检测适用于包装在塑料瓶或泡罩包装的固体制剂，例如片剂或胶囊。

The conclusionof the article is as follows:

该章节结论如下：

WVTR can bemeasured by the weight gain of a desiccant or by the weight loss ofwater in a packaging system in an environment with constant temperature andrelative humidity (RH). Packaging materials to be tested, which are filled withwater, show a constant vapour pressure difference along the walls of thecontainers. This constitutes an improvement in comparison to the current WVTRtesting according to <671>, in which the containers are filled withdesiccant and where the vapour pressure inside neither starts nor remainsat 0% rel. humidity.

WVTR可以通过称量干燥剂增重，或包装系统中恒定温度湿度（RH）环境中失水重量进行测定。将水装入待测包材，这时包材内壁与外界产生恒定的蒸汽压。这个方法相比于现在<671>中的WVTR检测方法是一种优化。原来的方法要在包材里装满干燥剂，这样包材里面的蒸汽压不是从0%RH湿度开始，也不会保持在0%RH湿度。

When containersare filled with water, many of the challenges can be avoided occurring with theuse of desiccants and with the handling of containers which must be filled withdesiccants - which is another advantage of the new method.

当容器装满水时，使用干燥剂以及对必须填充干燥剂的容器的处理可能避免

All otherinformation about the USP proposal can be found on the  USP Website of thePharmacopeial Forums (PF).

关于USP提议的其它信息可参见USP药典论坛官网。

Source: USP

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