anky1212
☆    

India,
2012-11-21 10:00
(4961 d 17:58 ago)

Posting: # 9565
Views: 7,157
 

 Retention samples [Study Per­for­mance]

Dear All,

After completion of clinical phase, I have completed reconciliation of IPs. Also, I have transferred the same to the storage cabinate provided in pharmacy area outside stroage chambers after confirmation from the sponsor.

My question is what should be range for temperature and humidity for storage of retention sample in pharmacy area.
Dr_Dan
★★  

Germany,
2012-11-21 13:23
(4961 d 14:35 ago)

@ anky1212
Posting: # 9566
Views: 5,961
 

 Retention samples

Dear anky1212
you should always store the samples at a temperature and humidity range needed to ensure stability of your product. If no special storage conditions are required then the temperature range of the room where the IP products are kept should be 20-25°C ± 5°C and humidity ≤ 50%. Alarm settings should be 15 & 30°C and > 50%.
I hope this helps.
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
127 visitors (0 registered, 127 guests [including 20 identified bots]).
Forum time: 04:58 CEST (Europe/Vienna)

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5