小弟不才请教各位版上神级QA/QC/或实验菁英们!! 敝司考试题目如下恳请惠教QQQQ Q: The Manufacturer makes a dialysis solution that is available in three different variants (different catalog/product/REF number for each variant). The main difference among the three variants is the concentration of the key component — present in a concentration of either 50 mg/L, 63 mg/L, or 78 mg/L. They have chosen to use HPLC (with appropriate detection method) to analyze these variants. This analytical method has been validated for its intended use. When the HPLC method is used to assay the key component concentration in the three product variants, it is important that the method can provide meaningful results in the required range. For the validation of ''Range'' of this HPLC method, which of the following would you expect the validation team to have tested during validation? 答案有下面选项 1. 3 replicates of blank. 2. 3 replicates of control standard at concentration 0.01 mg/L. 3. 3 replicates of control standard at concentration 40 mg/L. 4. 3 replicates of control standard at concentration 50 mg/L. 5. 3 replicates of control standard at concentration 60 mg/L prepared from different stock solution by a different operator 6. 3 replicates of control standard at concentration 60 mg/L tested by a different shift on a different instrument. 7. 3 replicates of control standard at concentration 60 mg/L. 8. 3 replicates of control standard at concentration 80 mg/L. 9. 3 replicates of control standard at concentration 95 mg/L. 10.3 replicates of control standard containing the component with known possible degradation products of the key component or containing a component known to exhibit HPLC behavior similar to the key component. 11. 3 replicates of sample from production lot 1. 12. 3 replicates of sample from production lot 2. 13. 3 replicates of sample from production lot 3. 14. 3 replicates of sample from production lot 4. 15. 3 replicates of sample from production lot 5. 16. None of these. 小弟选了1,3,4,7,8,9,/ 4,7,8/ 2,3,4,7,8,9/ 三次都0分...想请问大家选择当参考QQ 我预期的Range 应该是4,7,8要选才对, 但好像事情不是我想的这麽简单!! 请教各位神人大大了!!感谢 --

※ 发信站: 批踢踢实业坊(ptt.cc), 来自: 223.137.55.143 (台湾) ※ 文章网址: https://webptt.com/cn.aspx?n=bbs/Biotech/M.1684930803.A.DBA.html 真的...但34789我之前选过类似的但没分...他给分也很酷是看题目几个答案给分 两个答案就个别0.5这样, 所以感觉34789可能有错的答案... ※ 编辑: whwhyee (60.250.36.205 台湾), 05/25/2023 11:10:16