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LOQ FINISHED PRODUCT
Posted: Tue May 05, 2009 11:08 pm
by martinamarie
Hi, for LOQ for finished product, do you prepare the finished product at 0.05 % of the nominal concentration, or the pure standard solution at 0.05 %. Hope someone can help as I am a little confused
Tina
Posted: Wed May 06, 2009 10:54 pm
by tom jupille
LOQ of *what* in the finished product? As far as I know, you are not required to determine LOQ of the API for purposes such as potency or content uniformity.
Posted: Thu May 07, 2009 11:22 am
by Alex Buske
LOQ of the API is often determined as model for unknown impurities - that is valid only if the have the same absorption.
Alex
Posted: Thu May 07, 2009 5:32 pm
by tom jupille
Good point, Alex.
In which case my response would be "0.05% of whatever you are measuring".