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Searching for others thoughts on this. In drug development (and possibly onward), using a placebo chromatogram is common to subtract out placebo peaks that are not related substances to the API when testing a drug product. Do you use exact-matching excipient lots for placebo batches, meaning 3 placebos to exactly match the 3 unique registration batches regarding excipient lots used? Or, do you manufacture one of placebo and use it for peak subtraction out of the 3 active registration batches?
Each lot of excipients has the potential (although not likely) to have unique peaks on the chromatograms. FDA expects everyone to use different excipient lots in the 3 registration batches to challenge the thought that all excipient lots are identical in every way. Using exact matching placebos is an extension of this, I feel, but it is complicated to coordinate the various matching placebos to the active registration batches. Is it worth making 3 matching placebos?
Thank you for your thoughts!