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In the July/August 2007 issue of the Pharmacopeial Forum, the USP presents
the revised General Chapter <1119> "Near-Infrared Spectroscopy",
which is meant to be included in USP 31/2008.
The General Chapter on Near-Infrared Spectroscopy was completely revised in
order to make it clearer and better comprehensible. And the chapter was
adapted to the present-day implementations of NIR in the pharmaceutical industry. On the
whole, it was also an objective that the chapter should take account of the
increased usage of NIR in PAT (Process Analytical Technology)
implementations. Furthermore, some changes have been suggested for the
qualification of NIR instruments, especially regarding the subsection
"Wavelength Unvcertainty".
A new section in the chapter is titled "Outliers".
The text says that an NIR response that is not incorporated into qualitative
or quantitative calibration models does not necessarily indicate an
out-of-specification result. If an outlier occurs in an NIR measurement, the consequence must rather be that further tests are conducted on the sample by means of adequate methods. In case these additional tests show that the sample lies within the required specifications, the sample is acceptable.
These days, the General Chapters Expert Committee Advisory Panel of the USP is also working on the following two General Chapters:
<1038> Chemical Imaging
<1039> Chemometrics
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