I am trying to find the maximum acceptable limit of moisture content in powders for oral suspension, is there a reference that lists acceptable moisture content in pharmaceutical dosage forms on which I can rely?
Hi, if your product is pharmacopeial, take its monograph acceptance criteria, if not, calculate the cumulative moisture content percentage from moisture content of all formulation ingredients. Hope this will help.
From my experience maximum moisture content in powders for oral suspension is 1%
Ljiljana Krsteska does it not differ between drugs?
Do you happen to know of any reference I can rely on in that aspect?
if the moisture is higher than 1%, lumps form over time. Similarly, buffer excipients should be anhydrous.This is established by the long term stability study
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