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anky1212 ☆ India, 2012-11-21 10:00 (4961 d 04:34 ago) Posting: # 9565 Views: 7,154 |
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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. |
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Dr_Dan ★★ Germany, 2012-11-21 13:23 (4961 d 01:11 ago) @ anky1212 Posting: # 9566 Views: 5,957 |
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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 |
Ing. Helmut Schütz