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UV Performance qualification

UV Performance qualification

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Published by: trueindian28 on Apr 02, 2010
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11/15/2012

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Operational Qualification andPerformance Verification ofUV-visible Spectrophotometers
Technical Note
In principle, operational qualifica-tion and performance verification(OQ/PV) is not difficult to per-form, because spectrophotome-ters are relatively simple analyti-cal instruments. However, in prac-tice there are significant problemsbecause of the need to conformclosely to regulatory requirementsand because of the non-availabilityof appropriate and easy-to-usestandards.This technical note reviews theregulatory requirements, theadvantages and disadvantages of the standards currently availableand describes a new approachwhich significantly reduces thetime required to perform OQ/PV.
Introduction
In recent years quality require-ments, as outlined by ISO 9000,GLP, GMP and NAMAS, haveassumed increasing importanceand as a consequence, in the phar-maceutical industry, the recom-mendations of pharmacopeiashave also become more influen-tial. Verification of the continued proper performance of UV-visiblespectrophotometers is an impor-tant element of these qualityrequirements.
Definition
The terms operational qualification and perfor-mance verification are used interchangeably inthis publication. Both terms are used to mean aseries of tests designed to prove that an instru-ment is working within a set of required specifi-cations.
Agilent Technologies
Innovating the HP Way
 
Regulatory requirements
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.” 
1
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.).” 
2
The statement
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.
 
United States Pharmacopeia
3
The regulatory requirements forUV-visible spectrophotometers aredefined in the United StatesPharmacopeia (USP) XIII, Section851 on “Spectrophotometry andLight Scattering.” It states:
“Check the instrument for accuracy of calibration. … Thewavelength scale may be cali-brated also by means of suit-able glass filters, which haveuseful absorption bandsthrough the visible and ultravi-olet regions. Standard glassescontaining didymium (a mix-ture of praseodymium and neodymium) have been widelyused. Glass containing holmi-um is considered superior. For checking the photometricscale, a number of standardinorganic glass filters as wellas standard solutions of  known transmittance such as potassium chromate or potas-sium dichromate are avail-able.” 
The latter contains a cross-refer-ence:
“For further details regardingchecks on both wavelength and photometric scales of a spec-trophotometer, reference maybe made to the following publi-cations of the National Institute of Science andTechnology …” 
The NIST
4
 provides a range of solid and liquid standards fordetermining wavelength accuracy, photometric accuracy and straylight. The most important are sum-marized in table1.
Table 1NIST standardsSRM#TypeNIST Description
930Neutral density glass filtersThis SRM is for the verification and calibrationof the transmittance and absorbance scales ofvisible absorption spectrometers.931Cobalt and nickel solution in This SRM is for the verification and calibrationnitric/perchloric acid mixtureof the absorbance scales of ultraviolet and visibleabsorption spectrometers having narrow bandpasses.935Potassium dichromate solid for This SRM is for the verification and calibrationpreparation of test solutionof the transmittance and absorbance scales ofultraviolet absorption spectrometers.2031Metal-on-quartzThis SRM is for the verification and calibrationof the transmittance and absorbance scales ofultraviolet and visible absorption spectrometers.2034Holmium oxide solution in This SRM is for use in the verification andperchloric acidcalibration of the wavelength scale of ultravioletand visible absorption spectrometers havingnominal spectral bandwidths not exceeding 3nm.2032Potassium iodide solid for This SRM is for use in the assessment ofpreparation of test solutionheterochromic stray radiant energy (stray light) inultraviolet absorption spectrophotometers.

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