By lmm9607 on Tuesday, April 27, 2004 - 08:43 am:
Hi all, we are currently doing some assays of multi-vitamin tablets using HPLC. Does anyone what percent of analytes we should be testing in order to say we are meeting label claim? I mean, do we have to test for all the analytes, or can we pick a percentage of them at random? Thanks.
By Anonymous on Wednesday, April 28, 2004 - 08:11 pm:
My experience based on working in "big pharma":
If you are making a "label claim" on several components in a product, you must test everything. Otherwise, how can you make a label claim on what is there? Regulatory agencies, if applicable, may take unkindly to your decision to only test for some of the components.
By Anonymous on Sunday, May 2, 2004 - 04:28 pm:
That is a question that is most appropriately answered by the regulatory agency involved. In the US, that would be the FDA, and the answer would be that you have to test for all that you claim on the label.
By lmm9607 on Monday, May 3, 2004 - 08:38 am: