NEAR-INFRARED SPECTROSCOPY AS AN ALTERNATIVE TO ASSESS COMPLIANCE OF AMPICILLIN-TRIHYDRATE WITH COMPENDIAL SPECIFICATIONS

The suitability of near-infrared spectroscopy (NIRs) as an alternative to several compendial test methods such as identification, water cont ent and assay, in the release procedure of drug substances is demonstr ated with ampicillin trihydrate as an example. It is also shown that i n cases in which a manufacturing process is well under control, a 'sta ndard activity' can be assigned to a batch when its conformity with 's tandard quality' is proven by means of its NIR spectrum. For that purp ose a new quality parameter - the Conformity Index (CI) - is introduce d.