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LOQ FINISHED PRODUCT

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

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LOQ FINISHED PRODUCT

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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

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tom jupille
Site Admin
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.
-- Tom Jupille
LC Resources / Separation Science Associates
tjupille@lcresources.com
+ 1 (925) 297-5374

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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

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tom jupille
Site Admin
Good point, Alex. :oops:

In which case my response would be "0.05% of whatever you are measuring".
-- Tom Jupille
LC Resources / Separation Science Associates
tjupille@lcresources.com
+ 1 (925) 297-5374
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