3.2.9.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北京小汽车摇号结果查询
香蕉和芭蕉的区别
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 additives. The specification also applies to closures for containers for powders and freeze-dried products to be dissolved in water immediately before u.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 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 vulcanirs, accelerators, stabilirs, pigments) depends on the properties required for the finished article.
胶塞材料可以分为两类：Ⅰ类胶塞符合严格要求，是首选；Ⅱ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 tho which meet the strictest requirements and which are to be preferred; type II closures are tho which, having mechanical properties suitable for special us (for example, multiple piercing), cannot meet requirements as vere as tho
for the first category becau 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 closures chon for u 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 adverly,
—the closure does not yield to the preparation substances in quantities sufficient to affect its stability or to prent 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。
排列数公式
The closures are compatible with the preparation for which they are ud 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 ud during compatibility testing. When the supplier informs 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 sterilid before u.
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 ud. They are practically insoluble in tetrahydrofuran, in which, however, a considerable reversible swelling 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。
Identification of the type of rubber ud 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 aim of detecting differences in a batch compared to the closures ud for compatibility testing. One or more of the following analytical methods may be applied for this purpo: determination of relative density, determination of sulphated ash, determination of sulphur content, thin-layer chromatography 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1～5mm2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1～2g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-ction 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青少年体能训练营
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 condend near the top edge of the test-tube. Deposit a few drops of the pyrolysate on a potassium bromide disc and examine by infrared absorption spectrophotometry (2.2.24), comparing with the spectrum obtained with the type sample.
C. The total ash (2.4.16) is within ± 10 per cent of the result obtained with
the type sample.
检测TESTS
分析样品使用前须经清洗和灭菌。
雪花儿歌The samples to be analyd may be washed and sterilized before u.
阴虚吃什么饱和溶液。引进许多相当于表面积大约100m2大小的玻璃容器上的合适的胶塞，填满注射用水，煮沸5分钟并用注射用水冲洗5次。将清洗过的塞子放在广
口瓶上(Ⅰ类玻璃，3.2.1)，加200mL注射用水，称重。用硼硅酸盐玻璃杯盖住烧
瓶口。高压灭菌器中加热使得在20～30分钟内达到121±2℃的温度，保持30
出生证明怎么办分钟以上。注射用水优化原质量。摇动并立即以移注法分离橡胶与溶液。每次测
试前摇动饱和溶液。正月初九
空白溶液。同样方法制备200mL的注射用水空白溶液。
Solution S. Introduce a number of uncut closures corresponding to a surface area of about 100 cm2 in a suitable glass container, cover with water for
injections R, boil for 5 min and rin 5 times with cold water for injections R. Place the washed closures in a wide-necked flask (glass type I, 3.2.1), add 200 ml of water for injections R and weigh. Cover the mouth of the flask with a borosilicate-glass beaker. Heat in an autoclave so that a temperature of 121 ± 2 °C is reached within 20 min to 30 min and maintain at this temperature for 30 min. Cool to room temperature over about 30 min. Make up to the original mass with water for injections R. Shake and immediately parate the solution from the rubber by decantation. Shake solution S before each test
Blank. Prepare a blank in the same manner using 200 ml of water for injections R.
溶液外观。饱和溶液的乳白色较Ⅰ类胶塞的参比悬液Ⅱ和Ⅱ类胶塞（2.2.1）的参比悬液Ⅲ的颜色浅，没
有GY5（2.2.2，方法Ⅱ）溶液的外观颜色强烈。
Appearance of solution. Solution S is not more opalescent than reference suspension II for type I closures and is not more opalescent than reference suspension III for type II closures (2.2.1). Solution S is not more intenly coloured than reference solution GY5 (2.2.2, Method II).
酸碱度。在20ml的饱和溶液中滴加0.1mL的百里酚蓝溶液1。加不多于0.3ml 的0.01mol/l的氢氧化钠溶液或0.8ml的0.01mol/l的盐酸溶液分别得到蓝色或黄色。
Acidity or alkalinity. To 20ml of solution S add 0.1ml of bromothymol blue solution R1. Not more than 0.3ml of 0.01 M sodium hydroxide or 0.8 ml of 0.01 M hydrochloric acid is required to obtain either a blue or a yellow colour, respectively.
吸光度。5小时内测试制备好的饱和溶液。在0.45μm虑孔的薄膜滤器上过滤饱和溶液，弃掉少部分滤液。以空白液（见饱和溶液）作为补偿，在220～300nm 波长处检测滤出液的吸光度（2.2.25）。在那些波长范围内，Ⅰ类胶塞的吸光度没有超过0.2，Ⅱ类胶塞没有超过4.0。如必要，测量吸光度前稀释滤出液，将结果加以改正。
Absorbance. Carry out the test within 5 h of preparation of solution S. Filter solution S on a membrane filter having approximately 0.45 μm pores rejecting
