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Extracables in aqueous autoclavates for pharmaceutical closures of butyl rubber
MOD ISO 8871-1:2003
全国橡胶与橡胶制品标准化技术委员会胶乳制品分技术委员会(SAC/TC 35/SC 4)
1.1本标准规定了以丁基橡胶为主体材料制成的药用瓶塞高压水溶出物的化学要求与试验方法。本标准规定的性能要求是丁基橡胶药用瓶塞(以下简称瓶塞)高压水溶出物的最低要求。
1.2本标准未规定瓶塞与预定药剂的相容性研究步骤。
1.3本标准适用于丁基橡胶药用瓶塞。
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