% stability calculations and acceptance [Bioanalytics]

posted by Ramesh – India, 2007-10-24 10:56 (6820 d 19:52 ago) – Posting: # 1246
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Dear group members,

I have two queries regarding the calculation of the % stability.
Query1
% stability calculation:
one by calculating the % accuracy. i.e 85-115% of nominal conc.

second by calculation of response ratio of test/reference. (area response ratio)

in both of them which is the correct method for the calculation of the stability.

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.

with regards,
Ramesh.V

with regards,

Ramesh

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