|
"序号","评价维度","指标","公司产品注册标准","2020版中国药典标准","欧洲药典9.0版标准"
|
|
"123","杂质含量","卵清蛋白含量","≤60ng/mL","≤200ng/mL","≤500ng/mL"
|
|
"","","蛋白质含量","≤360μg/mL","≤400μg/mL","≤600μg/mL"
|
|
"","","游离甲醛含量","≤25μg/mL","≤50μg/mL","≤200μg/mL"
|
|
"4","有效成分纯度","蛋白质含量/血凝素含量","≤3.0","≤4.5","≤6.0"
|