RQA GLP Committee
You need to define what the test item is. If the ethanolic extract is going to be the test item, then it is this that will need to be characterised. If the extract is the way the test item is prepared to be administered to the test system then concentration, stability etc. information will be needed. If the extract is what is defined as the test item and what is applied to the test system, then that will need to be characterised. Depending on where you are in the World and what your plans are for the study results, the FDA requirements may not be relevant, but if your are in an OECD member country then you should follow the OECD requirements.