Hi,
I would appreciate any information or pathways (index), on how to write a SOP regarding general criteria for the right way of executing HPLC methods: Including number replicate injection, bandwidth and so on.
Thanks,
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By tom jupille on Tuesday, July 2, 2002 - 08:56 am:
Check the following:
http://www.ich.org/ich5q.html
(ICH - Analytical)
http://www.fda.gov/cder/guidance/2396dft.htm
(analytical procedures and methods validation)
http://www.fda.gov/cder/guidance/cmc3.pdf
(reviewer guidance validation of chromatographic methods)