《ep检测-欧洲药典3.2.9》由会员分享，可在线阅读，更多相关《ep检测-欧洲药典3.2.9（9页珍藏版）》请在金锄头文库上搜索。
1、3.2.9.注射用粉针和冻干粉末容器胶塞标准注射用粉针和冻干粉末容器胶塞标准 3.2.9. RUBBER CLOSURES FOR CONTAINERS FOR AQUEOUS PARENTERAL PREPARATIONS, FOR POWDERS AND FOR FREEZE-DRIED POWDERS 粉和冻干粉水肠外制剂胶塞材料通过高分子物质（弹性体）硫化（交联）， 加入合适的添加剂获得。该规范也适用于粉和冻干粉在使用前立即被溶解在水中 的封闭容器。该规范不适用于硅橡胶制成的胶塞（在 3.1.9 处理，不封和油管的有 机硅弹性体），夹层封闭或漆封。弹性体由天然胶或合成物质的聚合，加聚或
2、缩 聚产生。主要组成部分和各种添加剂的性质（例如硫化剂、促进剂、稳定剂、色 素）取决于成品所需的属性。 Rubber closures for containers for aqueous parenteral preparations for powders and for freeze-dried powders are made of materials obtained by vulcanisation (cross-linking) of macromolecular organic substances (elastomers), with appropriate additive
3、s. The specification also applies to closures for containers for powders and freeze-dried products to be dissolved in water immediately before use.The specification does not apply to closures made from silicone elastomer (which are dealt with in 3.1.9. Silicone elastomer for closures and tubing), to
4、 laminated closures or to lacquered closures. The elastomers are produced from natural or synthetic substances by polymerisation, polyaddition or polycondensation. The nature of the principal components and of the various additives (for example vulcanisers, accelerators, stabilisers, pigments) depen
5、ds on the properties required for the finished article. 胶塞材料可以分为两类：类胶塞符合严格要求，是首选；类胶塞有着适 用于特殊用途（如多孔冲孔）的机械性能，但因为它们的化学组成，不能满足第 一类那样的需求。 Rubber closures may be classified in 2 types : type I closures are those which meet the strictest requirements and which are to be preferred; type II closures are thos
6、e which, having mechanical properties suitable for special uses (for example, multiple piercing), cannot meet requirements as severe as those for the first category because of their chemical composition. 供特殊制备使用选择的胶塞如： 与胶塞相关的制备部件不能吸附到胶塞的表面，不能迁移或通过胶塞的表 面而影响制备。 胶塞成批的不屈服的准备物质的数量足以影响其稳定性或目前的毒性风 险。 The c
7、losures chosen for use with a particular preparation are such that : the components of the preparation in contact with the closure are not adsorbed onto the surface of the closure and do not migrate into or through the closure to an extent sufficient to affect the preparation adversely, the closure
8、does not yield to the preparation substances in quantities sufficient to affect its stability or to present a risk of toxicity. 胶塞与它们使用其整个有效期的准备兼容。该制剂的制造商必须从供应商获 得保证，胶塞的组成不发生变化，这是相同的兼容性测试期间使用的封闭。当供 应商通知制造商编制的构成变化时，兼容性实验必须重复，全部或部分，视变化 的性质而定。 胶塞在使用前必须经过清洗和消毒。 The closures are compatible with the prepa
9、ration for which they are used throughout its period of validity. The manufacturer of the preparation must obtain from the supplier an assurance that the composition of the closure does not vary and that it is identical to that of the closure used during compatibility testing. When the supplier info
10、rms the manufacturer of the preparation of changes in the composition, compatibility testing must be repeated, totally or partly, depending on the nature of the changes. The closures are washed and may be sterilised before use. 特征 CHARACTERS 橡胶塞是弹性的；它们是透明的或不透明的，没有特有的颜色，后者随所使 用的添加剂的颜色而定。它们几乎不溶于四氢呋喃，但
11、是，在其中可能发生相当 多的可逆溶胀。它们是同类的，基本上是于闪光灯和不定材料分离出来（如纤维、 杂质颗粒、废旧橡胶）。 Rubber closures are elastic ; they are translucent or opaque and have no characteristic colour, the latter depending on the additives used. They are practically insoluble in tetrahydrofuran, in which, however, a considerable reversible swe
12、lling may occur. They are homogeneous and practically free from flash and adventitious materials (for example fibres, foreign particles, waste rubber). 胶塞类型的橡胶的鉴定不属于本规范的范围。下面给出鉴定试验区分弹性体 和非弹性体，但不区分各类橡胶。一个批次的用于兼容性试验的闭包，其差异性 可用其它鉴定测验检测。一种或多种一下的分析方法可用于此目的：相对密度测 定，硫酸盐灰分测定，含硫量测定，提炼物的薄色层分离法，干馏物的红外分光 光度测量。
13、Identification of the type of rubber used for the closures is not within the scope of this specification. The identification test given below distinguishes elastomer and non-elastomer closures but does not differentiate the various types of rubber. Other identity tests may be carried out with the ai
14、m of detecting differences in a batch compared to the closures used for compatibility testing. One or more of the following analytical methods may be applied for this purpose: determination of relative density, determination of sulphated ash, determination of sulphur content, thin-layer chromatograp
15、hy carried out on an extract, ultraviolet absorption spectrophotometry of an extract, infrared absorption spectrophotometry of a pyrolysate. 鉴定 IDENTIFICATION A. 弹性体是这样一种材料， 由专人可以将一个横截面 15mm2拉伸至至 少原长的两倍。保持原长两倍一分钟，它可以在 30 秒内恢复到原长的 1.2 倍。 B.热 12g 的试样，在耐热的试管里放于明火上干燥，并继续加热至热解 蒸汽凝结在试管顶部边缘附近。放少量的干馏物在溴化钾压片
16、上，通过红外分 光光度法测量（2.2.24），同所获得的试样光谱比较。 C.结果的总灰分（2.4.16）在10%以内为标准样品。 A. The elasticity is such that a strip of material with a cross-section of 1 mm2 to 5 mm2 can be stretched by hand to at least twice its original length. Having been stretched to twice its length for l min, it contracts to less than 1.2 times its original length within 30 s. B. Heat 1 g to 2 g in a heat-resistant test-tube over an open flame to dry the sample and continue heating until pyrolysate vapours are conden
