method validation for liquid samples and lyophilized product

[miro2009]

hello
I'd like to ask in case of validation of a method for quantification of a lyophilized product, how would the analysis repeatability (injection of 6 different preparations) tests be performed:reconstitution of 6 different vials and injection? wouldn't this include an additional variable of content variation from one vial to another (even if content uniformity is acceptable).
and in case of liquid finished product that is injected with no sample pretreatment needed, what would multiple analysts be required to do in this case? it would be just sampling the liquid into the HPLC vial??

also, is it acceptable to specify that my Accuracy range is 70-130% (as its a method used for content uniformity), and for the Range test, to specifiy the same (70-130%)? I'm having accuracy problems with the 50% so I can't go for the 50-150% range.

I would appreciate your feedback and comments.

[JGK]

For the analysis repeatability, why dont you reconstitute the 6 vials and mix an equal aliquot of each to produce a 'pooled' sample, using that would eliminate the content variation form the calculation.