2020-04-28 09:54

Posting: # 21353
Views: 2,122

 Preservative efficacy test - E coli [Regulatives / Guidelines]

Hello All,

For preservative testing of parenterals, Ph. Eur. specifies, but does not make E. coli mandatory for sterile multi-dose parenterals. However, USP makes it mandatory for E. coli testing. Can someone help me to understand the reason behind it? Can we request a waiver from E.coli testing from US and if yes, what should be our argument?

Thanks a lot in advance!
 Admin contact
20,793 posts in 4,353 threads, 1,445 registered users;
online 16 (0 registered, 16 guests [including 12 identified bots]).
Forum time: 10:29 CEST (Europe/Vienna)

In God we trust;
all others must bring data.    W. Edwards Deming

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