preservative specifications Contribution from Emanuela Cagnoni written on 7/15/2008 at 09:39
Following a variation I submitted to my Agency (AIFA- Italian Ministry)to add a new manufacturer, they asked me to revised the specifications about preservatives I have in my pharmaceutical formula (topic cream), now I have an analythical specification 80-120% but they asked me to tightened to 90-110%, may I know the exact guideline or Pharmacopoeia reference to justify this request?
Regards
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