[求救] 考試問題求助! HPLC Validation question

看板Biotech作者whwhyee (wyeee)時間11月前 (2023/05/24 20:20)推噓6(6推 0噓 6→)

留言12則, 4人參與討論串1/1

小弟不才請教各位版上神級QA/QC/或實驗菁英們!! 敝司考試題目如下懇請惠教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? 答案有下面選項 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. 小弟選了1,3,4,7,8,9,/ 4,7,8/ 2,3,4,7,8,9/ 三次都0分...想請問大家選擇當參考QQ 我預期的Range 應該是4,7,8要選才對, 但好像事情不是我想的這麼簡單!! 請教各位神人大大了!!感謝 -- ※ 發信站: 批踢踢實業坊(ptt.cc), 來自: 223.137.55.143 (臺灣) ※ 文章網址: https://www.ptt.cc/bbs/Biotech/M.1684930803.A.DBA.html

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jabari

05/24 20:59, 11月前 , 1^F

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j66661g

05/24 22:46, 11月前 , 2^F

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ko363630

05/25 10:12, 11月前 , 3^F

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