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Tutorial NIRWare 1.5 Software Manual

5.5. Content Uniformity Test (CUT)

5.5.1. Development of an application for Content Uniformity Testing

(CUT) of Solid Dosage Forms

The US Pharmacopeia, the European Pharmacopoeia and the Japanese Pharmacopoeia describe

detailed procedures to test the content uniformity of single dosage units. The test indicates the uniformity

of the active pharmaceutical ingredient (API) in the dosage unit, such as tablets or capsules, based on the

assay of a defined number of samples. This test is requested for batch release.

 Develop a quantitative application as described in the chapter “Creating a quantitative

application” for the API.

 After the quantitative application is successfully developed and tested, create a copy of

the application.

 To activate the CUT procedure, click on to show the advanced settings of the

application.