There are many regulatoryrequirements that govern the useof UV-visible spectrophotometers.The following sections review themost important of these.
Good laboratory practice andgood manufacturing practice
Good laboratory practice (GLP)and good manufacturing practice(GMP) requirements concerningthe validation of instruments canbe summarized as:
“Documented verification thatthe system or subsystem per- forms as intended throughout representative or anticipatedoperating ranges.”
In reference to spectroscopy, thefollowing is suggested:
“Where appropriate, periodic performance checks should becarried out (for example, …the resolution, alignment andwavelength accuracy of spec-trophotometers, etc.).”
intended andanticipated operating ranges
iscritical when considering anOQ/PV strategy. For example, if the intended purpose is to mea-sure absorbance in the UV region(as is the case for most pharma-ceutical analyses), it is not appro- priate to verify photometric accu-racy in the visible range—it mustbe done in the UV region and preferably at several wavelengths.Similarly, it is not appropriate to verify wavelength accuracy at the656.1nm deuterium line becausethis is not a reliable indicator of wavelength accuracy in the UVregion. Further, as the vast majori-ty of samples to be measured inthe pharmaceutical laboratory aresolutions contained in cuvettes, itcan be argued that the use of solidor emission standards is inappro- priate, because these standardshave different optical characteris-tics from the samples that will beanalyzed.It is worthwhile noting that the American Standard TestingMethods (ASTM) and the NationalInstitute of Standards andTechnology (NIST) make similarstatements. For example, the ASTM states that the wavelengthsused for calibration should, if pos-sible, bracket the analytical wave-length and NIST comments on theuse of their various standards.