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by phillc73 2423 days ago
The first thing to do would be look up the Scientific Discussion or Monograph as filed with the FDA for the brand name product. With the details obtained from there, you'd know what to test for.

The first steps would be assay and impurity tests for the active pharmaceutical ingredients (API). If you bought tablets you'd probably want to do dissolution as well.

If everything looked fine after that, I'd still be concerned about uniformity. If you just performed dissolution on half a dozen tablets, how do you know all the tablets are the same from the whole supply?

Next question is then stability. What happens to the API over an extended time period? Does it deteriorate due to climate or poor storage conditions?

The main issue is quality control. Even an approved generic has to file with the FDA (or equivalent of wherever you are) concerning processes, batch sizes, critical quality attributes etc.