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VP ☆ 2009-12-19 07:56 (6029 d 23:36 ago) Posting: # 4506 Views: 3,958 |
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Dear All, During the subject sample analysis we found more samples above the ULOQ, so we stopped the analysis and performed the partial validation to exceed the CC range. Old range was 5.408-1514.312 ng/mL and revised range is 5.419-2507.398 ng/mL. For first range we have performed autosampler carryover experiment but for revised range we did not perform the same experiment. My querry is 1. we have to perform the autosampler carryover or not? 2. As analysis is completed & exp. is not performed what should we document in the Project report? Regards VP Edit: Category and subject line changed. [Helmut] |
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Debbie ★ India, 2009-12-19 17:22 (6029 d 14:10 ago) @ VP Posting: # 4510 Views: 3,214 |
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Hi, you should perform the carryover test when you have extended the calibration range. for the second query, why cant you perform the test now? the evaluation does not take much time and resources, rather than preparing and injecting few samples. ❝ During the subject sample analysis we found more samples above the ULOQ, ❝ so we stopped the analysis and performed the partial validation to exceed ❝ the CC range. i am wondering what partal validation you have performed? since when you have extended the calibration range, you should perform the complete validation. i request other forum members to comment. Debbie. |
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Ohlbe ★★★ France, 2009-12-20 00:52 (6029 d 06:40 ago) @ Debbie Posting: # 4512 Views: 3,092 |
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Dear Debbie and VP, ❝ i am wondering what partal validation you have performed? ❝ since when you have extended the calibration range, you should perform the ❝ complete validation. Well... As I heard in a recent presentation, if you want to call it a partial validation because you won't study stock solution stability again  Why not ? And selectivity is already done too.But indeed you have to go back to linearity, within and between run precision and accuracy, stability experiments, etc. Regards Ohlbe |
Ing. Helmut Schütz