Preservative efficacy test - E coli [Regulatives / Guidelines]

posted by ping4santosh  – India, 2020-04-28 09:54 (788 d 05:27 ago) – Posting: # 21353
Views: 2,600

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!
Cheers,
SKM

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