44-74684PRD_LAMBDAPharmaceuticalApplications | Ultraviolet–Visible Spectroscopy | Verification And Validation

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Life Sciences Optoelectronics Instruments Fluid Sciences P R O D U C T UV/Vis Spectroscopy Pharmaceutical Applications The Lambda Series N O T E w w w. p e r k i n e l m e r. c o m Quality control in the pharmaceutical industry is heavily regulated. UV/Vis systems must be reliable, simple to use, and flexible. The spectrometer must offer the right accessories to accommodate your sample type while ensuring reliable results. The system must also meet all appropriate industry standards and
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  Pharmaceutical ApplicationsThe Lambda Series    w   w   w .   p   e   r    k    i   n   e    l   m   e   r .   c   o   m Quality control in the pharmaceu-tical industry is heavily regulated.UV/Vis systems must be reliable,simple to use, and flexible. Thespectrometer must offer the rightaccessories to accommodate yoursample type while ensuringreliable results. The system mustalso meet all appropriate industrystandards and guidelines for goodlab practices, as well as providedocumentation to prove compli-ance.For routine analyses the LambdaSeries will simplify the analyticalprocess while ensuring dataintegrity and regulatorycompliance. From simple concen-tration measurements and puritydetermination, to content unifor-mity and dissolution testing, thereis a Lambda system that is rightfor you. Quality systems for dependableresultsDouble beam optics provideexcellent long-term stabilityEuropean Pharmacopoeia standarcompliantExcellent stray radiation specificatifor increased dynamic rangeTools for IPV and IQ/OQProven optical design for robust anreliable performance P R OD U CT  N OT E   The heart of your system,the spectrometer The spectrometer is the funda-mental source of your data and isthe key to reliable and accurateresults. With a proven optical sys-tem, the Lambda Series complieswith the most stringent worldstandards for photometric accura-cy, wavelength accuracy, spectralresolution and stray radiation.The Lambda Series is designed toproduce quality results in routineusage. Three different models areavailable:ãLambda 25 (double beam,1 nm fixed resolution)ãLambda 35 (double beam, 0.5,1, 2 and 4 nm variableresolution)ãLambda 45 (double beam, 0.5,1, 2 and 4 nm variable resolu-tion and pre-monochromator) Key Features UV/Vis Spectroscopy Life Sciences OptoelectronicsInstrumentsFluid Sciences  EPRequirement: Stray radiation  Test Solution: Potassium Chloride solution forstray radiationUV spectrum of a 1.2%Potassium Chloride solutionrecorded with Lambda 35demonstrating the extraordinarystray-light specification. Theabsorbance value at 200 nmrequired by EP is 2. EPRequirement: Wavelength accuracy  Test Solution: Holmium Perchlorate solution forwavelength accuracySpectrum of HolmiumPerchlorate Solution recordedwith Lambda 35 for wavelengthaccuracy verification. EPRequirement: Resolving power  Test Solution: Toluene in Hexane for spectralresolutionComparison between 1 nm (red)and 2 nm (blue) slits for EPresolution power test. Only the1 nm slit setting complieswith EP.  Instrument Performance Verification (IPV) IPV made easy - that is what our pro-gram is designed to do for you. Allmodels in the Lambda Series are test-ed in the factory using a calibratedset of reference materials. Includedwith your spectrometer is a certifi-cate that summarizes the significantQuality Assurance (QA) tests thathave been performed. In addition,the system includes ready-to-runmethods for validating performance.And, if you need help or on-siteassistance, our customer supportteams are ready to assist you; ensur-ing that your system is performingto specification at all times. Ready to use standard sets PerkinElmer supplies ready-to-usesecondary standards for checkingand verifying instrument perform-ance. A certificate documenting thevalues of the secondary standardmaterials is provided. UV WinLab™software will automatically comparethe measured values with the certi-fied value. Based on these results andthe instrument tolerances, a pass/faildecision will be made and reported. The automated validation routine comes standard with the PerkinElmer UV WinLab softwarepackage and will automatically perform instrument validation with pass/fail decision andrespective reports.Instrument Validation protocol obtained with the Validation Routine in UV WinLab. Secondary Standards Standard Set Stray Radiation Standard Sets Pharmacopoeia (P/N B0507805)(P/N B2500099)(P/N B2500100) Set of certified secondary standards Ready to use sealed cells Ready to use secondary standardstraceable to NIST reference materials. for stray light determination.for instrument validation according to DAB/USP.Set contains:Kit contains sealed cells filled with: Includes sealed cells containing:Three neutral density (gray glass) filtersSodium iodide solutionHolmium perchlorate solutionfor checking photometric accuracy in Sodium nitrite solutionPotassium dichromate solutionthe visible region, nominally at 0.3A, Potassium chloride solutionPotassium chloride solution0.5A and 1.0A. Also included is a Water (blank)Toluene in hexaneholmium oxide glass filter for checking Water (blank)wavelength calibration in the UV and 0.005 M sulfuric acid solution (blank)visible range. Standards available for the Lambda Series of UV/Vis spectrometers.  © 2002 PerkinElmer, Inc .All rights reserved. PerkinElmer is a trademark of PerkinElmer, Inc. UV WinLab software is a trademark of PerkinElmer Instruments LLC.D-6400AKG0602XXPrinted in USA PerkinElmer Instruments 710 Bridgeport AvenueShelton, CT 06484-4794 USAPhone: (800) 762-4000 or(+1) 203-925-4600www.perkinelmer.com SpectrometerSoftwareStandards* AdditionalStandards*Performance Validation*Spare parts*SampleHandling* Lambda 25 UV/Vis Spectrometer(P/N L600000B).Fixed 1 nm bandwidth.Wavelength range190 nm - 1100 nm.(Includes software)UV WinLab software for fullinstrument and accessorycontrol.Standard set Pharmacopoeia (P/N B2500100)Set of Secondary standards(P/N B0507805)Performance Validation Guide(P/N 09935026)Tungsten Halogen Lamp(P/N B0114620) for Lambda 25Deuterium Lamp (P/N N0160917)for Lambda 25Liquid sample handling and/ortemperature control. QA/QC Applications Lambda 35 UV/Vis Spectrometer(P/N L600000C). Variable 0.5 nm, 1 nm, 2 nm and4 nm bandwidth.Wavelength range190 nm - 1100 nm.(Includes software)UV WinLab software for fullinstrument and accessorycontrol.Standard set Pharmacopoeia (P/N B2500100)Set of Secondary standards(P/N B0507805)Standard set Stray Radiation (P/N B2500099)Performance Validation Guide(P/N 09935026)Tungsten Halogen Lamp(P/N B0114620) for Lambda 35Deuterium Lamp (P/N N0160917)for Lambda 35Liquid sample handling and/ortemperature control. Method development Lambda 45 UV/Vis Spectrometer(P/N L600000D) Variable 0.5 nm, 1 nm, 2 nm and4 nm bandwidth.Pre-monochromatorWavelength range190 nm – 1100 nm.(Includes software)UV WinLab software for fullinstrument and accessorycontrol.Standard set Pharmacopoeia (P/N B2500100)Set of Secondary standards(P/N B0507805)Standard set Stray Radiation (P/N B2500099)Performance Validation Guide(P/N 09935026)Tungsten Halogen Lamp(P/N B0114620) for Lambda 45Deuterium Lamp (P/N N0160917)for Lambda 45Liquid sample handling and/ortemperature control Research & Method development *Optional Recommended Configurations The Lambda Series of UV/Vis spectrometers are PC-controlled systems operating with UV WinLab software. Therefore, aPC and printer are required. PerkinElmer offers a range of quartz cells with different volumes and pathlengths. See our e -ssentials consumables catalog for further details. PerkinElmer Support The Lambda Series of UV/Visible spectrometers are part of a wide range of analytical systems offered by PerkinElmer forpharmaceutical R&D and QA/QC applications. All of our instruments, including the Lambda Series are backed by ourstaff of highly trained field sales, product specialists, service engineers and technical support personnel. PerkinElmer isfully committed to helping you achieve the results you need to further your research.
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