definiens: means and includes all data, inaterials, specific ' chemical compounds and intermediates thereof, . synthetic a.n, d. mapufa¢turing PJ."otocol ~ and procedures ; purification parameters arid ' data that includes, but is not limited to, ~tatiqfi~ phase information " * ( such as, . column . size, stationary.pliase . cofuposftioll, ' hiatl ~ actu1 : er ) and mobile phase information ( such as, solvents and ' additives useairith¢~:rti ~ bi1e ~ ph~$e, elrition rate, . elution grlldient, retention ' . time ) ; · techl1ical:~drtdj : i .. techriical : infmil'iatioii"khbw ~ liQw, expertiseand trade, within the Area