An example of IS response. Need your helps. [Bioanalytics]
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Clearly from that graph the instrument response has been increased gradually over a period of time. I think the acceptance criteria is +/- 25% of the IS response of the average of accepted CC and QC. The criteria fulfilled because the response of IS in CC and QC increased along with study samples, as per SOP.
There might be many reasons behind the enhancement of the response of IS,
- System may not stabilized while submitting the batch.
- May be column is not saturated enough.
- May be the category of the molecule require more stability runs to stabilize. etc.
But personally speaking, I have come across this type of scenarios in the past. But possibilities of the change in concentrations are less, because we determine concentrations based on the area ratio. Looking at the data, I think the response of IS and analyte increased proportionally as the QC samples are passed resulting a successful analytical run.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
Complete thread:
- An example of IS response. Need your helps. Shuanghe 2020-05-26 12:56
- An example of IS response. Need your helps.Sukalpa Biswas 2020-05-26 13:49
- An example of IS response. Need your helps. Shuanghe 2020-05-26 16:32
- An example of IS response. Need your helps. Ohlbe 2020-05-26 17:46
- An example of IS response. Need your helps. Ohlbe 2020-05-26 14:42
- Placement of CC Helmut 2020-05-26 15:35
- An example of IS response. Shuanghe 2020-05-26 16:32
- An example of IS response. Ohlbe 2020-05-26 17:27
- Placement of CC Ohlbe 2020-05-26 17:32
- Placement of CC Helmut 2020-05-26 19:03
- Duplicate LLOQ and ULOQ Ohlbe 2020-05-26 19:43
- Duplicate LLOQ and ULOQ Helmut 2020-05-27 16:30
- Duplicate LLOQ and ULOQ Ohlbe 2020-05-26 19:43
- Placement of CC Helmut 2020-05-26 19:03
- An example of IS response. Shuanghe 2020-05-26 16:32
- Placement of CC Helmut 2020-05-26 15:35
- An example of IS response. Need your helps. ElMaestro 2020-05-26 15:44
- An example of IS response. Need your helps. ksreekanth 2020-07-06 13:37
- Trend analysis as per recent USFDA guideline dshah 2020-08-01 07:32
- Only for QCs; encouraged ≠ required Helmut 2020-08-01 14:13
- Only for QCs; encouraged ≠ required dshah 2020-08-03 09:17
- Deviation from the mean response Helmut 2020-08-07 13:28
- Only for QCs; encouraged ≠ required Shuanghe 2020-08-03 13:56
- Broken-stick regression Helmut 2020-08-04 18:04
- Only for QCs; encouraged ≠ required dshah 2020-08-03 09:17
- Only for QCs; encouraged ≠ required Helmut 2020-08-01 14:13
- An example of IS response. Need your helps.Sukalpa Biswas 2020-05-26 13:49