Bioequivalence and Bioavailability Forum

❝ Query1

❝ % stability calculation:

❝ one by calculating the % accuracy. i.e 85-115% of nominal conc.

❝ Percent Stability

[%]Stability = 100 x Mean Conc. of Stability Samples /
Mean Conc. of Comparison Samples

❝ Query 2:

❝ Precision and Accuracy:

❝

❝ For the determination of the stability, fresh CC and QC samples are

❝ prepared, in such case is it necessary to prove the precision and accuracy

❝ of the freshly prepared QC samples. i mean to say whether it is necessary a

❝ to analysis the P& A batch along with the stability samples.

No need to prepare freshly prepared QC samples along with fresh CC. Compare the stability QC samples with first day P&A batch QC samples.

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Edit: Full quote removed. Please see this post! [HS]