Only for QCs; encouraged ≠ required [Bioanalytics]

posted by dshah – India, 2020-08-03 09:17 (258 d 04:28 ago) – Posting: # 21818
Views: 2,739

Hi Helmut!
As per standard SOP - "If the response of internal standard in a sample varies by more than 60% for the isotopically labeled internal standard from the mean ISTD response of CC and QC samples of a particular entire run, then repeat the analysis of the sample under reason Significant variations in response of internal standard"
However - there is no guideline which specifies the limit for variation for IS. Thus, it could be 30/40/50/60 - as per CRO's SOP/requirement/Experience.
The interesting thing could be - whether the QC's analyte/IS standard response are within acceptable range - i.e. whether the QC's were acceptable? if the IS standards response are high, there is possibilities that the QC will be on lower side. I am wondering what other things can be directly correlated and what can be the reason for CRO's acceptability of variation in IS response?
Regards,
Dshah

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,509 registered users;
online 14 (0 registered, 14 guests [including 3 identified bots]).
Forum time: Sunday 13:45 CEST (Europe/Vienna)

Nothing fails like success because you do not learn anything from it.
The only thing we ever learn from is failure.
Success only confirms our superstitions.    Kenneth E. Boulding

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5