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T/CVDA 团 体 标 准 T/CVDA 9-2024 动物疫苗复合皂苷佐剂 (YSK M101 ) Combined saponin adjuvant for animal vaccine (YSK M101 ) (发布稿) 2024-09-29 发布 2024-10-01 实施 中国兽药协会发布 ICS 11.220 B 42 全国团体标准信息平台 目 录 前 言 ................................ ................................ ................................ ................................ ................................ .... 1 1 范围 ................................ ................................ ................................ ................................ ................................ .. 1 2 规范性引用文件 ................................ ................................ ................................ ................................ .............. 1 3 术语和定义 ................................ ................................ ................................ ................................ ...................... 1 3.1 佐剂 ................................ ................................ ................................ ................................ ....................... 1 3.2 皂苷 ................................ ................................ ................................ ................................ ....................... 1 4 缩略语 ................................ ................................ ................................ ................................ .............................. 2 5 质量要求 ................................ ................................ ................................ ................................ .......................... 2 5.1 基本要求 ................................ ................................ ................................ ................................ ............... 2 5.2 制备 ................................ ................................ ................................ ................................ ....................... 2 5.3 性状 ................................ ................................ ................................ ................................ ....................... 2 5.4 技术指标 ................................ ................................ ................................ ................................ ............... 2 5.5 装量检查 ................................ ................................ ................................ ................................ ............... 3 6 用法用量 ................................ ................................ ................................ ................................ .......................... 3 7 检验方法 ................................ ................................ ................................ ................................ .......................... 3 7.1 性状检验 ................................ ................................ ................................ ................................ ............... 3 7.2 pH测定 ................................ ................................ ................................ ................................ .................. 3 7.3 含量测定 ................................ ................................ ................................ ................................ ............... 3 7.4 无菌检验 ................................ ................................ ................................ ................................ ............... 4 7.5 细菌内毒素测定 ................................ ................................ ................................ ................................ ... 4 7.6 安全检验 ................................ ................................ ................................ ................................ ............... 4 8 检验规则 ................................ ................................ ................................ ................................ ..............

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