Provide the formulation for a typical batch and for an administration unit, e.g. one tablet, 5 ml of oral solution, or the contents of an ampoule or bag of large volume parenteral solution, etc.
Include excipients that may be removed during processing, those that may not be added to every batch (e.g. acid and alkali), and the qualitative and quantitative composition of any tablet coating, capsule shell and inked imprint on the dosage form. State any overages. State the function(s) of each excipient (e.g. antioxidant, lubricant, binder).
Indicate any substances whose content may be varied (e.g. inked imprint, tablet coating). Ranges in the content of excipients need justification and explanation how the content is decided for each batch.