分析方法验证- 中间精密度

halfmoon · 发表于 2022-11-26 11:52:55

欢迎您注册蒲公英

您需要登录才可以下载或查看，没有帐号？立即注册

x

本帖最后由 halfmoon 于 2022-11-26 12:06 编辑

多数国内对中间精密度的验证内容不全。
中间精密度的目的：不同条件时，此方法的误差在允许范围内
不同条件包括：操作者，设备，柱子，试剂，（实验室等）
色谱序列举例：

HPLC Analysis Sequence (IntermediatePrecision)

Name Injections Note

Blank 3 System suitability - blank

STD1 5 System suitability - standard 1

STD2 1 Systemsuitability - standard 2 (check standard)

SS STD 1 System suitability - sensitivitystandard

RS STD 1 System suitability - resolutionstandard

Repeatability-1 1 Repeatability

Repeatability-2 1 Repeatability

Repeatability-3 1 Repeatability

Repeatability-4 1 Repeatability

Repeatability-5 1 Repeatability

Repeatability-6 1 Repeatability

STD2 1 System suitability - standard 2(check standard)

A-low-1 1 Accuracyat concentration lower than standard

A-low-2 1 Accuracyat concentration lower than standard

A-low-3 1 Accuracy at concentration lower thanstandard

A-100-1 1 Accuracy at the same concentration asstandard

A-100-2 1 Accuracy at the same concentration asstandard

A-100-3 1 Accuracy at the same concentration asstandard

STD2 1 Systemsuitability - standard 2 (check standard)

A-high-1 1 Accuracy at concentration higher thanstandard

A-high-2 1 Accuracy at concentration higher thanstandard

A-high-3 1 Accuracy at concentration higher thanstandard

Sample-prep1 1 long-termsolution stability

Sample-prep2 1 long-termsolution stability

STD2 1 Systemsuitability - standard 2 (check standard)

Totalinjections 31

halfmoon · 发表于 2022-11-26 12:10:01

Sample-prep1 1 long-term solution stability
Sample-prep2 1 long-term solution stability
这两个样品也是 Blank Control (也可以是长期稳定性样品）

halfmoon · 发表于 2022-11-26 12:11:37

本帖最后由 halfmoon 于 2022-11-26 12:13 编辑

重新发一下：

HPLC Analysis Sequence (Intermediate Precision)

Name                      Injections                Note
Blank                            3                      System suitability - blank
STD1                            5                      System suitability - standard 1
STD2                            1                      System suitability - standard 2 (check standard)
SS STD                         1                      System suitability - sensitivity standard
RS STD                         1                      System suitability - resolution standard
      Repeatability-1       1                      Repeatability
      Repeatability-2       1                      Repeatability
      Repeatability-3       1                      Repeatability
      Repeatability-4       1                      Repeatability
      Repeatability-5       1                      Repeatability
      Repeatability-6       1                      Repeatability
STD2                            1                      System suitability - standard 2 (check standard)
      A-low-1                1                      Accuracy at concentration lower than standard
      A-low-2                1                      Accuracy at concentration lower than standard
      A-low-3                1       Accuracy at concentration lower than standard
      A-100-1                1       Accuracy at the same concentration as standard
      A-100-2                1       Accuracy at the same concentration as standard
      A-100-3                1       Accuracy at the same concentration as standard
STD2                            1       System suitability - standard 2 (check standard)
      A-high-1                1       Accuracy at concentration higher than standard
      A-high-2                1       Accuracy at concentration higher than standard
      A-high-3                1       Accuracy at concentration higher than standard
      Sample-prep1          1       blank control
      Sample-prep2          1       blank control
STD2                               1    System suitability - standard 2 (check standard)
      Total injections       31

jchaoli · 发表于 2022-12-9 14:48:33

只有1台仪器，该怎么做中间精密度？如果连人员都只有1人呢？

halfmoon · 发表于 2022-12-10 13:05:55

jchaoli 发表于 2022-12-9 14:48
只有1台仪器，该怎么做中间精密度？如果连人员都只有1人呢？

请仔细读：

” 中间精密度的目的：不同条件时，此方法的误差在允许范围内
不同条件包括：操作者，设备，柱子，试剂，（实验室等）“

中间精密度的目的尽可能寻找你公司的变量，比如：两个厂区的不同实验室，　以保证公司的数据的准确性。当然老板为了省钱，只有一根柱子，你也没办法

棒棒爹 · 发表于 2022-12-20 09:32:26

halfmoon 发表于 2022-12-10 13:05
请仔细读：

” 中间精密度的目的：不同条件时，此方法的误差在允许范围内

感觉您说的中间精密度怎么和重现性有点意思一样了

halfmoon · 发表于 2022-12-22 08:35:29

棒棒爹发表于 2022-12-20 09:32
感觉您说的中间精密度怎么和重现性有点意思一样了

中间精密度包括重现性

[分析仪器] 分析方法验证- 中间精密度

欢迎您注册蒲公英