FT at -20 storage [Bioanalytics]

posted by Compliance – India, 2012-02-29 06:36 (5231 d 18:59 ago) – Posting: # 8183
Views: 3,891

Dear All,

Is it suggested to perform FT stability also if the sample storage is also proven at -20 storage additionally by performing long term stability in matrix for 15 to 30 days duration? The FT experiment is already proven for -70 in which the entire validation samples were stored.

For more clarity, the stability estimation done on -20 to handle some temperature variation if any occurs while storing samples at -70 condition. So if the stability is proven at -20 then the entire storage condition -70 to -20 is covered.

kindly give your suggestion.

Regards,

Compliance

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
403 visitors (0 registered, 403 guests [including 27 identified bots]).
Forum time: 02:35 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got.    Janis Joplin

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