| 查看: 695 | 回复: 0 | |||
zhangy_1977铜虫 (小有名气)
|
[求助]
FDA缺陷信中的对照品一致性
|
|
最近看到一个FDA的缺陷信问题，如下。 OBSERVATION 4 Laboratory controls do not include the establishment of scientijfically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Specifically, during the establishment o f system suitability for chromatographic analyses, the firm did not prepare or use a second working standard solution (Check Standard Solution) to confirm the potency, accuracy and purity of the working standard solutions (Primary Standard Solution). A single standard preparation was used to determine the potency, accuracy and purity of the active pharmaceutical ingredient in the sample solution. 问下大神，这个怎么做，是用一个对照品，配成两个对照溶液，进行比较？还是用两个对照品分别配成两个对照溶液进行比较啊？第一个对照与第二个对照溶液如何计算比较？ |
回复此楼» 猜你喜欢
有机合成以后会不会被AI改变？做科研的虫友怎么看
已经有7人回复
-
求合成方法
已经有6人回复
-
上海工程技术大学 激光智能制造课题组 2027级博士研究生招生
已经有4人回复
-
现代”学阀”该如何界定
已经有12人回复
-
国社科系统bug了，是不是要放榜了？
已经有10人回复
-
课题组招2027级博士 上海工程技术大学 激光智能制造方向
已经有4人回复
-
我的奶奶
已经有3人回复
