Dear all,
5% is it considred significant chenge in logterme stability study?
Thanks in advence.
Depends on your specification. If the assay specification is 99.0-101.0%, then 5.0% would be a huge change and produce an OOS!
Change is ALWAYS relative and you must use a decimal (see USP’s general notes on numbering and truncating numbers).
Dear Boomer, thank you very much for your reply.
I meant, is significant chenge (OOT) applicable for long terme stability or just for Accelerated and intermediate study?
For OOS it is clear for me.
I am bit confused about what is mentionned in ICH guidline.
ICH Flow shart talks about accelerated condition only.
NB: I am still learning anglish.
Regards.
The answer is YES! Remember, that samples on ‘long term stability’ represent commercial lots of drug product sold to the general public. This ‘fact’ makes them ‘very’ important.
The only difference between ‘accelerated’ and ‘long term stability’ is the required temperature and humidity (which has a great importance on the growth in concentration of the related substances, and thus the decrease of potency of the drug product) .