16 usp tests, 1 full usp test, Usp tests – Metrohm Vision – Diagnostics User Manual
Page 58: Full usp test
56
▪▪▪▪▪▪▪
16
USP Tests
USP Tests are included for users who must run tests in support of regulatory requirements such as the
United States Pharmacopoeia (USP) General Information Chapter on Near-Infrared Spectroscopy
<1119>.
Included in the USP tests are:
•
Noise
•
Low-flux noise
•
Wavelength accuracy
•
Photometric linearity test
The tests are configured to give results as recommended in the USP <1119> General Information
Chapter in Near-Infrared Spectroscopy. The test results are stored in the Diagnostic Database that is
accessed from the USP Tests dropdown menu. The results are not shown in the Diagnostic Database
Viewer.
The USP tests are not as thorough as the Metrohm-recommended tests, taking fewer spectral
measurements per test. For Metrohm XDS analyzers, it is not sufficient that the instrument pass the
USP tests to ensure transferability of calibration models between instruments. Calibration transfer on
the XDS can only be ensured if the instrument has passed all of the Metrohm recommended
diagnostic tests for the instrument.
The USP tests are accessed on the menu under USP Tests or from the USP shortcut button on the top
menu. When the shortcut button is selected, the full suite of tests is run (and requires that the
Photometric Linearity Setup was already done for the given analyzer). This manual explains the menu
items in their order of appearance.
The user has the option of running the full suite of tests, or just one of the components.
16.1
Full USP Test
Choosing the option to run the Full USP Test will run through the entire suite of USP tests. To choose
this option requires that the Photometric Linearity (or IPV) Setup has been completed. The setup
creates a file, RUSPxxxx that is stored in the Vision\ DiagDB folder. This file is the initial reading of the
photometric standards on the instrument and is required for the Photometric Linearity Test. If more
than one module is used with a given monochromator, a separate setup file must be created for each
module.