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- Posts: 33
- Joined: Sat Jan 15, 2011 2:53 am
I am performing uniformity of dosage units via weight calculation (USP<905>). My drug product is in liquid form. When calculating AV, I need use assay% value.
My questions are:
1) Can I decide assay% by calculation only, i.e. assay%=(average of 10 individual weight/ label claim)*100%
Or 2) do I have to run a seperate HPLC assay method, calculate assay% and use this value for AV calculation?
Thanks.