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Alongside the theoretical evaluation of risk described above, there is often the need to examine this experimentally through conducting appropriate purging or spiking experiments. This is most likely required where a moderate to high risk of potential carryover into the API has been defined, i.e. where control Option 4 is not considered appropriate. Spiking refers to the practice of adding in a fixed quantity, or spike, of the material to be tracked, in order to confirm a quantifiable baseline. Purging refers to the extent to which the material in question is removed out of the downstream material or API as a consequence of the processing conditions to which it has been exposed.