Qualification of UV VISIBLE SPECTROPHOTOMETER

Qualification of UV VISIBLE SPECTROPHOTOMETER

1. QUALIFICATION OF UV -
VISIBLE
SPECTROPHOTOMETRY
Dr.K. VENKATESWARA RAJU
SHRI VISHNU COLLEGE OF PHARMACY

2. QUALIFICATION
VALIDATION:Itisaactofdemonstratinganddocumenting
thattheprocessoperateseffectivelyandreproduciblyto
produceaproductmeetingitspredeterminedspecifications
andqualityattributes.Theaimofvalidationistoshowthat
thecriticalstepsareundercontrolandleadcontinuouslyto
thedesirablequality.
QUALIFICATION:Qualificationisanactorprocesstoassure
somethingcomplieswithsomeconditions,standardorspecific
requirements.

3. QUALIFICATION:Qualificationisanactorprocessto
assuresomethingcomplieswithsomeconditions,
standardorspecificrequirements.
DesignQualification:Documentedevidencewhichshowsthat
theplantdesignagreeswiththedesignspecificationsofthe
customer.
InstallationQualification:Writtenevidenceisgiventhatall
partsofequipmentareinstalledaccordingtotheequipment
supplier’sandpurchasespecifications.
Operationalqualification:Documentedevidencewhichshows
thatallpartsoftheplantandequipmentworkwithintheir
specificationsandprocessparameters.
PerformanceQualification:Providesdocumentedevidencethat
allpartsofaplantandotherprocessesproduceproductsof
specifiedqualityunderconditionsofnormalproductionfora
longerperiodoftime

4. UV-Visiblespectroscopyisconcernedwithultra
violetandvisibleregionswhichrangesfrom200-
780nm.

5. INSTALLATIONPROCEDURE
WhiletheUVinstrumentwasshippedafterthepreciseadjustment
andinspectionatthefactory,itisrecommendedtoinstall
accordingtothefollowingproceduressoastoprovideits
optimumperformanceandtomeettheuser’sdemands.
INSTALLATIONSITE
Roomtemperatureduringuseof15to35◦C.
Outofdirectsunlight.
Nostrongvibrationorcontinuousweakvibration.
Nostrongmagneticfieldsorelectromagneticfields.
Humidityof45to80%.
Nocorrosivegasesororganicorinorganicgaseswith
absorptivityintheultravioletrange.
Smallamountofdust.

6. ACCEPTANCEPROCEDURES:

7. PERFORMANCE QUALIFICATION PARAMETERS
Wavelengthaccuracy
Itisdefinedasthedeviationofthewavelengthreadingatanabsorption
bandandemissionbandfromthewavelengthoftheband.
Acceptance:±nminUVrange(200-380nm)and±nminvisiblerange
(380-800nm)
Threerepeatedscanofthesamepeakshouldbewithin±0.5nm
Straylight
Straylightisdefinedasthedetectedlightofanywavelengththatisout
sidethebandwidthofthewavelengthselected.
Acceptance:thetransmittanceofthesolutionina1cmcellshouldbeless
than0.01ortheabsorbancevalueshouldbegreaterthan2

8. RESOLUTIONPOWER
TheresolutionoftheUV-VISspectrometerisrelatedtoitsspectralband
width.Thesmallerthebandwidththefinertheresolution.TheSBW
dependsontheslitwidthandthedispersivepowerofthemonochromator.
Acceptance:Theratiooftheabsorbanceat269nmandabsorbanceat266
nmshouldbegreaterthan1.5
NOISE
Noiseisthemeasurementaffectstheaccuracyatthebothendofthe
absorbancescale.Photonnoisefromthelightsourceaffectstheaccuracy
ofthemeasurementleadstolowabsorbance.
Acceptance:TheRMSnoiseshouldbelessthan0.001AU
BASELINEFLATNESS
Theflatbaselinetestdemonstratesthattheabilityoftheinstrumentto
normalizethelightintensitymeasurementandthespectraloutputat
differentwavelengththroughoutthespectralrange.
Acceptance:Themeasurementistypicallylessthan0.01AU

9. STABILITY
Thelampintensityisafunctionofthelampage,temperaturefluctuation
andwavelengthofthemeasurement.Thesechangescanleadtoerrorsin
thevalueofthemeasurements,overanextendedperiodoftime.
Acceptance:Thedeflectionislessthan0.002AU/hr
PHOTOMETRICACCURACY
Photometricaccuracyisdeterminedbycomparingthedifferencebetween
themeasuredabsorbanceofthereferencematerialandtheestablished
value.
Acceptance:Sixreplicatemeasurementsofthe0.006%w/vofthe
potassiumdichromatesolutionat235,257,313and350nmshouldbeless
than0.5%RSD.
LINEARITY
Thelinearitydynamicrangeofmeasurementislimitedbystraylightat
highabsorbanceandbynoiseatlowabsorbance.Theaccuracyofthe
quantificationofthesampledependsontheprecisionandlinearityofthe
measurements.
Acceptance:Correlationcoefficientr˃0.999

10. REFERENCES
Pharmaceutical Validation; ANUPRIYA N. R; Department of Pharmaceutical
Quality Assurance