uniformity by weight veriation

[darasc0211]

Hi,

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.

[tom jupille]

You should be able to use the average. (your option 1).