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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 guidelines for good lab practices, as well as provide documentation to prove compliance. For routine analyses the Lambda Series will simplify the analytical process while ensuring data integrity and regulatory compliance. From simple concentration measurements and purity determination, to content uniformity and dissolution testing, there is a Lambda system that is right for you.

The heart of your system, the spectrometer The spectrometer is the fundamental source of your data and is the key to reliable and accurate results. With a proven optical system, the Lambda Series complies with the most stringent world standards for photometric accuracy, wavelength accuracy, spectral resolution and stray radiation. The Lambda Series is designed to produce quality results in routine usage. Three different models are available: Lambda 25 (double beam, 1 nm fixed resolution) Lambda 35 (double beam, 0.5, 1, 2 and 4 nm variable resolution) Lambda 45 (double beam, 0.5, 1, 2 and 4 nm variable resolution and pre-monochromator)

Key Features
Quality systems for dependable results Double beam optics provide excellent long-term stability

European Pharmacopoeia standard compliant

Excellent stray radiation specificatio for increased dynamic range Tools for IPV and IQ/OQ

Proven optical design for robust and reliable performance

EP Requirement: Stray radiation Test Solution: Potassium Chloride solution for stray radiation UV spectrum of a 1.2% Potassium Chloride solution recorded with Lambda 35 demonstrating the extraordinary stray-light specification. The absorbance value at 200 nm required by EP is 2.

EP Requirement: Wavelength accuracy Test Solution: Holmium Perchlorate solution for wavelength accuracy Spectrum of Holmium Perchlorate Solution recorded with Lambda 35 for wavelength accuracy verification.

EP Requirement: Resolving power Test Solution: Toluene in Hexane for spectral resolution Comparison between 1 nm (red) and 2 nm (blue) slits for EP resolution power test. Only the 1 nm slit setting complies with EP.

Instrument Performance Verification (IPV) IPV made easy - that is what our program is designed to do for you. All models in the Lambda Series are tested in the factory using a calibrated set of reference materials. Included with your spectrometer is a certificate that summarizes the significant Quality Assurance (QA) tests that have been performed. In addition, the system includes ready-to-run methods for validating performance. And, if you need help or on-site assistance, our customer support teams are ready to assist you; ensuring that your system is performing to specification at all times. Ready to use standard sets PerkinElmer supplies ready-to-use secondary standards for checking and verifying instrument performance. A certificate documenting the values of the secondary standard materials is provided. UV WinLab software will automatically compare the measured values with the certified value. Based on these results and the instrument tolerances, a pass/fail decision will be made and reported.

The automated validation routine comes standard with the PerkinElmer UV WinLab software package and will automatically perform instrument validation with pass/fail decision and respective reports.

Instrument Validation protocol obtained with the Validation Routine in UV WinLab.

Secondary Standards (P/N B0507805) Set of certified secondary standards traceable to NIST reference materials. Set contains: Three neutral density (gray glass) filters for checking photometric accuracy in the visible region, nominally at 0.3A, 0.5A and 1.0A. Also included is a holmium oxide glass filter for checking wavelength calibration in the UV and visible range.

Standard Set "Stray Radiation" (P/N B2500099) Ready to use sealed cells for stray light determination. Kit contains sealed cells filled with: Sodium iodide solution Sodium nitrite solution Potassium chloride solution Water (blank)

Standard Sets "Pharmacopoeia" (P/N B2500100) Ready to use secondary standards for instrument validation according to DAB/USP. Includes sealed cells containing: Holmium perchlorate solution Potassium dichromate solution Potassium chloride solution Toluene in hexane Water (blank) 0.005 M sulfuric acid solution (blank)

Standards available for the Lambda Series of UV/Vis spectrometers.

Recommended Configurations The Lambda Series of UV/Vis spectrometers are PC-controlled systems operating with UV WinLab software. Therefore, a PC 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.

QA/QC Applications Spectrometer Lambda 25 UV/Vis Spectrometer (P/N L600000B). Fixed 1 nm bandwidth. Wavelength range 190 nm - 1100 nm. (Includes software)

Method development Lambda 35 UV/Vis Spectrometer (P/N L600000C). Variable 0.5 nm, 1 nm, 2 nm and 4 nm bandwidth. Wavelength range 190 nm - 1100 nm. (Includes software) UV WinLab software for full instrument and accessory control. Standard set "Pharmacopoeia" (P/N B2500100)

Research & Method development Lambda 45 UV/Vis Spectrometer (P/N L600000D) Variable 0.5 nm, 1 nm, 2 nm and 4 nm bandwidth. Pre-monochromator Wavelength range 190 nm 1100 nm. (Includes software) UV WinLab software for full instrument and accessory control. Standard set "Pharmacopoeia" (P/N B2500100)

Software

UV WinLab software for full instrument and accessory control. Standard set "Pharmacopoeia" (P/N B2500100)

Standards*

Additional Standards*

Set of Secondary standards (P/N B0507805)

Set of Secondary standards (P/N B0507805) Standard set "Stray Radiation" (P/N B2500099)

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 45 Deuterium Lamp (P/N N0160917) for Lambda 45 Liquid sample handling and/or temperature control

Performance Validation* Spare parts*

Performance Validation Guide (P/N 09935026) Tungsten Halogen Lamp (P/N B0114620) for Lambda 25 Deuterium Lamp (P/N N0160917) for Lambda 25

Performance Validation Guide (P/N 09935026) Tungsten Halogen Lamp (P/N B0114620) for Lambda 35 Deuterium Lamp (P/N N0160917) for Lambda 35 Liquid sample handling and/or temperature control.

Sample Handling*

Liquid sample handling and/or temperature control.

*Optional

PerkinElmer Support The Lambda Series of UV/Visible spectrometers are part of a wide range of analytical systems offered by PerkinElmer for pharmaceutical R&D and QA/QC applications. All of our instruments, including the Lambda Series are backed by our staff of highly trained field sales, product specialists, service engineers and technical support personnel. PerkinElmer is fully committed to helping you achieve the results you need to further your research.

PerkinElmer Instruments 710 Bridgeport Avenue Shelton, CT 06484-4794 USA Phone: (800) 762-4000 or (+1) 203-925-4600 www.perkinelmer.com 2002 PerkinElmer, Inc .All rights reserved. PerkinElmer is a trademark of PerkinElmer, Inc. UV WinLab software is a trademark of PerkinElmer Instruments LLC.

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KG0602XX Printed in USA