Home Forums General Discussion Covering upper T°C claim with extended storage time ICH Q1A(R2) Reply To: Covering upper T°C claim with extended storage time ICH Q1A(R2)

KazuyoP
Participant
Post count: 2

Dear John,

Thanks a lot for you clear answer.

We’ll try to combine an accelerated storage condition (with reference real-time at 35 °C) with an extended real-time 50% longer to see if they will accept our “worst case” proposed conditions.

p.s. RH is ruled out since packaging is non-porous and systems within are completely dry

Thanks for your support again, waiting for other opinions.

KR