Bioequivalence and Bioavailability Forum

Dear Members,

The following query is with regard to acceptance of analytical batch. Please opine:

In an analytical batch, lower limit of quantification failed to meet the acceptance criteria, we will consider next standard in the calibration curve. If there is interference with respect to RT of analyte in standard blank and it is more than 20 % of LLOQ (however its failed), but less than 20 % of the next accepted standard.

Can we accept the batch?

(Reference: Interfering components is accepted where the response is less than 20% of the lower limit of quantification for the analyte)


Thanks & Regards,
Avinash