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 content and assay, in the release procedure of drug substances is demonstrated with ampicillin trihydrate as an example. It is also shown that in cases in which a manufacturing process is well under control, a 'standard activity' can be assigned to a batch when its conformity with 'standard quality' is proven by means of its NIR spectrum. For that purpose a new quality parameter--the Conformity Index (CI)--is introduced.