Identity

The attribute showing that a material or product is what it is claimed to be. For an antibody, an identity test might be peptide mapping or a charge profile; for a cell therapy product, surface markers together with the chain of identity linking the lot to its patient. In Japanese Pharmacopoeia monographs and many specifications the identity test is headed with a different word (確認試験), rendered as Identification in the English JP, while this term is used more in biologics, cell therapy and cell bank documents.