label claim

The label claim is the amount of active drug a dosage unit is declared to contain, as printed on the label: the 500 mg on a paracetamol box, the 10 mg per tablet, the 100 mg in 5 mL of a syrup. It is the promise the manufacturer makes about how much drug is inside.

Quality testing checks how closely the real content matches this claim. An assay measures the actual amount of drug, and the result is usually expressed as a percentage of label claim; pharmacopoeias set acceptance limits, often around 90 to 110 percent, within which a batch is considered to meet its claim.

The label claim is also the reference point for content uniformity, which checks that individual units do not stray too far from the stated amount, and it underpins dosing: a prescriber and patient trust that each unit holds what the label says. Manufacturers may add a slight overage during production to ensure the claim is still met at the end of shelf life as the drug slowly degrades.