The minimum data required at the time of submitting the dossier should be from six months accelerated and six
months long-term stability studies conducted on at least two batches, not less than one batch of at least pilot
scale and a second batch which may be smaller (e.g. for solid oral dosage forms, 25 000 to 50 000 tablets or
capsules). For oral solutions in plastic containers, the parameters studied should include water loss.
