bharathi
☆    

India,
2019-09-26 12:20

Posting: # 20649
Views: 1,964
 

 12 units from 12 different bottles should be used - Dissolution for Suspensions [Regulatives / Guidelines]

Hi,

I wonder why some of the USFDA BE recommendations has "Conduct comparative dissolution testing on 12 dosage units each of all strengths of the test and reference products" and other specify as "A total of 12 units from 12 different bottles should be used"?

What is the criteria for 2 different statements for suspensions

Regards,
Bharathi
jag009
★★★

NJ,
2019-10-22 21:29

@ bharathi
Posting: # 20714
Views: 912
 

 12 units from 12 different bottles should be used - Dissolution for Suspensions

Hi,

» I wonder why some of the USFDA BE recommendations has "Conduct comparative dissolution testing on 12 dosage units each of all strengths of the test and reference products" and other specify as "A total of 12 units from 12 different bottles should be used"?

Please cite reference for the 2nd recommendation.

J
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