The answer is, no. You don’t have to test it against the full specification. You need to use your
knowledge of the history of the product. Where have you historically had problems with failing?
For most compounds you would typically look at impurities rather than the full specification. But
you need to make an evaluation for each process based on your data. If you don’t have history, if
you’re just starting up a process, what should you do? The same, start with looking at the
impurities in each batch.
