Bioequivalence and Bioavailability Forum

LC-MS/MS automatic integration [Bioanalytics]

posted by najatmughrabi – 2008-11-19 08:32 (5634 d 23:30 ago) – Posting: # 2728
Views: 5,243

Dear Forum Subscribers
Good morning

1. I have been reviewing some LC-MS/MS chromatograms and found out that integration mode changes automatically within the same run from "Valley" to "Base to base" to "exponential skim" and vice versa in a haphazard way for both the analyte and the internal standard without any external modification. Would appreciate why this is happening and would it affect the integrity of the generated data from regulatory point of view (both European and US-FDA)?
   
2. Part of the LC-MS/MS analysis involves performing system suitability at the beginning; the analyst modified the chromatograms to get a better base-line for the internal standard. Calculations of the CV before modification fails the acceptance criteria while those after modification pass the acceptance criteria. Kindly advice how is this looked into from regulatory point of view? Does this invalidate the whole run even if the standard curve and QCs pass?

Thanking you in advance for your valuable feedback
Have a nice day
Najat

Complete thread:

• LC-MS/MS automatic integrationnajatmughrabi 2008-11-19 07:32 [Bioanalytics] 
  • LC-MS/MS automatic integration Helmut 2008-11-19 12:51
    • LC-MS/MS automatic integration najatmughrabi 2008-11-19 14:30
      • Manual re-integration Helmut 2008-11-19 15:35
  • LC-MS/MS automatic integration Ohlbe 2008-11-20 00:18