UV-visible spectroscopysolutions for pharmaceutical

analysis

Commitment to ease of use

With the advent of microprocessor andPC control, UV-visible instruments havebecome more powerful but, at the sametime, they have become more difficult touse – especially for simple measure-ments. Agilent Technologies is committedto reversing this trend by developingintuitive, easy-to-use instruments.

Commitment to GLP

Agilent Technologies believes thatmanufacturers have the responsibility tohelp instrument users conform to therequirements of GLP, GMP and 21 CFRpart 11.

The challenge

Provide UV-visible spectroscopy solutionsthat satisfy the diverse needs of analysts inroutine QA/QC, research, and methoddevelopment laboratories.

Commitment to standards

In the modern analytical laboratorycompatibility of electronic communicationis a major contributor to productivity.Agilent Technologies uses industry-standard hardware and operatingsystems, and develops software thatadheres to industry-standard guidelinesand thereby helps with easy datainterchange.

Commitment to solutions

Nowadays, simply buying an instrumentoften does not solve the problem. AgilentTechnologies, as a global leader indesigning and manufacturing test,measurement and monitoring instruments,as well as semiconductor and opticalcomponents, addresses this by offeringcomplete solutions for modern analyticallaboratories.

Based on the Agilent 8453spectrophotometer dedicated solutionsare available for• QA/QC labs• method development labs• research labs

In addition special support for 21 CFR part11 can be added to these solutions.

Commitment to technology

Hewlett-Packard revolutionized thedesign of UV-visible instruments withdiode-array technology in 1979 and todayAgilent Technologies continues thiscommitment to developing new technol-ogy as a means to provide you with better,cost-effective solutions.

The solution

Systems based on PC-controlledspectrophotometers and a rangesoftware – each with features to meet theneeds of specific users – plusaccessories to enable manual or fully-automated measurements on a widevariety of samples.

W h a t m a k e s A g i l e n t ’ s U V - v i s i b l e s y s t e m s

Agilent 8453 UV-visible spectroscopysystem comprising Agilent 8453

spectrophotometer, Agilent ChemStationsoftware running on an HP personal

computer, and HP DeskJet printer

d i f f e r e n t ?

”Complete,powerful systems

that solve yourproblems”

Agilent Technologies and GLP

Agilent Technologies plays a leading rolein defining the GLP-relatedresponsibilities of manufacturers andusers. And, Agilent Technologiesimplements features in its products thatenable users to comply with GLPregulations quickly, reliably, andproductively.

Standards kit

OQ/PV is made even easier using AgilentTechnologies standards kit, which meetsthe needs of both the United States andEuropean Pharmacopoeias. The kitcomprises standard solutions in snap-open glass ampules which areinexpensive, easy-to-use and traceable.The standards let you check forphotometric accuracy, wavelengthaccuracy, stray light and resolution.

Validation begins with the manufacturer ...

Agilent Technologies designs anddevelops products according todocumented procedures. Each product isvalidated before it leaves the factory. TheDeclaration of Conformity document isyour assurance that the spectrophoto-meter meets specifications. TheDeclaration of System Validationdescribes procedures used in softwareand system development and is yourassurance of software quality.

The challenge

Help analysts comply with GLPregulations, meet inspector’s standards,and increase productivity.

G o o d L a b o r a t o r y P r a c t i c e

... and continues on site

All you need for Installation Qualification(IQ) and Operational Qualification/Performance Verification (OQ/PV) isprovided for both the spectrophotometerand system software. Full documentationis included and, where appropriate,procedures are supported by software tosave time. IQ and OQ/PV can beperformed by the user or are available asservices from Agilent Technologies.

Electronic records and signatures

The Agilent ChemStation software incombination with Windows NT and theoptional Security Pack can be configuredto support the requirements for electronicrecords and signatures for a closedsystem as defined in FDA 21 CFR part 11.Tools and products for system installationand operational qualification alsocomplete this solution.

Access Control

Two levels of permissions are defined andmanaged by the system administrator asuser groups within Windows NT. Allaccess control features of Windows NTcan be applied such as password aging,uniqueness or account lock.The Agilent ChemStation login is basedon these user groups and checks thepermission rights of the users. Forexample, at the manager level, you can

develop, modify and save methods, at theoperator level you only can load and runthese methods but cannot save newmethods or change existing ones. In theabsence of the operator, the runningsystem can be locked for unattendedoperation.

Method integrity

The software saves all methodparameters (meta data) in a single,checksum-protected binary file includingmethod history. Existing method filescannot be overwritten.

Data integrity

Agilent Technologies systems measureand save full spectra, even if your currentmethod only uses a single wavelength.Data is automatically annotated with date,time, instrument identifier, operator name,and sample information added by theuser. Result files include all information toreprocess the results such as raw data,the complete method as well as logbookson the run. Even in the case of theoperator having deleted a spectrum fromthe set of spectra, the deleted spectrumand the operators comment are savedwith the result file and are available forreview.

The solution

Systems with built-in tools to help complywith GLP regulations and for verificationof the system components.

Choose the testyou need

Data security

The protection of electronic records isone of the most important aspects of datasecurity. The Agilent ChemStationsoftware saves data in checksum-protected binary files. In combinationwith Windows NT file system permissionsettings, Agilent ChemStation users cannot modify, rename, delete or move any ofthe data or method files.

Audit trail

The run logbook is automaticallygenerated by the Agilent ChemStationand is always stored with the result file. Itcontains information such as, who andwhen the spectra were measured, saved,reprocessed, the calibration modified orthe method changed.

Electronic signatures

Users can sign result files electronicallywith their user ID and password. Thepurpose of the signature as well as theuser name, date and time are stored inthe signature logbook together with theindividual result file.

Agilent Technologiesstandards kit and

optional OQ/PV hardwarekit make OQ/PV easier

and save substantial time

”Easycompliance to GLP

for increasedproductivity”

Easy to use

The Agilent 8453 UV-visible spectroscopysystem may well be the easiest UV-visiblesystem you will ever use. Three steps areall you need to get results.

Graphical user interface

Usability tests performed with actualusers in their own labs initiated acompletely new approach to userinterface design. The Agilent 8453 UV-visible spectroscopy system usessymbolic graphics to:• make the system intuitive, easy to

learn, and easy to use,• provide confirmation of current

status at a glance,• provide visual confirmation of

actions, and• provide fast access to frequently

performed activities.

S o l u t i o n s f o r g e n e r a l p u r p o s e t a s k s

Automation

A single dialog box makes setup forautomated analyses easy and quick. Youcan use automation to guide an operatorthrough a series of manualmeasurements, or combine it withsampling accessories to provide semi- orfully automated analysis. The automationfunction controls• the Agilent sipper system• Agilent XY autosampler or Gilson

autosampler• the Agilent multicell transport

The optional control samples allow you torun an automatic system suitability testbefore quantitative analyses.

Compatibility

The Agilent ChemStation uses theMicrosoft Windows NT environment soyou can run other programs, such asword processors and spreadsheets, at thesame time, and transfer data using copy-and-paste.

Clear and simple reports

Generating reports could not be easier.Simply click the printer icon in the toolbarand a standard report is printed. Whenpossible this standard report is printed ona single sheet of paper. The report formatdepends upon the task in use but all

The solution

The Agilent 8453 UV-visible spectroscopysystem, combining the PC-controlledAgilent 8453 spectrophotometer with theMicrosoft Windows NT-based AgilentChemStation software.

”Easy tolearn and easy

to use for increasedproductivity”

reports include essential GLP informationsuch as method and data file name, date,time, operator, overlay of sample spectraand result table.

1. Select the taskyou want

2. Enter the parameters

3. Do the measurement

Your results are displayed automatically

Print a report

The challenge

Provide a powerful and productive systemfor routine and occasional users that iseasy to use and integrates seamlessly inthe modern laboratory.

Ease of use

The biochemical analysis software buildson the Agilent 8453 UV-visiblespectroscopy system. It provides theadditional tasks that the biochemist needsand uses the same easy-to-use graphicaluser interface. Preprogrammed methodsfor protein and nucleic acid analysis helpyou get up and running fast.

Proteins and nucleic acids

Standard methods are provided for thequalitative and quantitative analysis ofnucleic acids and proteins:• 260/280 nm ratios (with optional

reference at 320 nm) for nucleic acidpurity

• Warburg-Christian calculation ofconcentration of nucleic acid or proteinin mixtures

• Biuret, Lowry, Modified Lowry, Bradford,Bicinchoic acid, and Trinitrobenzenesulfonate protein quantification methods

Microsampling

A frequent problem for the biochemist isthe small sample volumes available foranalysis. With the Agilent 8453spectrophotometer you can usemicrocells requiring as little as 15 µl ofsample for qualitative and precisequantitative analysis.

The challenge

Provide an easy-to-use UV-visible systemthat meets the specific needs of thebiochemist.

Full spectra are alwaysacquired, even inmulticell kinetics, so youcan reevaluate results atleisure

Multicell kinetics

For productivity with enzyme kineticmeasurements the optional eight-positionmulticell transport can be used. You canfreely configure which positions containsamples and blanks and you can select tosubtract the rate of one cell from theothers.You can evaluate kinetic rates at a singlewavelength or subtract a referencewavelength. Rate calculation methodsinclude initial rate, zero order, first order,and delta absorbance. For a single cellyou can also display and calculate ratesat up to six individual wavelengths.

The solution

Add biochemical analysis software to theAgilent 8453 UV-visible spectroscopysystem for multicell kinetics, thermaldenaturation, and protein/nucleic acidanalysis capabilities.

S o l u t i o n s f o r b i o c h e m i c a l a n a l y s i s

”Keybiochemical

applications in asingle, easy-to-use

system”

Multicomponent analysis

Multicomponent UV-visible analysis canprovide a real alternative to time-consuming separations. Fast electronicscanning, spectral curve fitting ofstandards to unknowns, excellentwavelength reproducibility, andmaximum-likelihood statistics make surethat results are superior to those obtainedwith conventional mechanical-scanningspectrophotometers. Calibration is simpleand fast using pure standards or mixturesof standards.Statistics for the fit of the standards to thesample spectra give you confidence inyour results.

Advanced automation

With the advanced automation capabilityyou can perform fully automaticallycomplex measurement, data evaluation,and report generation sequences usingsingle or multiple methods for differenttypes of samples. It can also be used toguide an operator through a complexsequence of manual measurementoperations. Complex methods or

Powerful data analysis

The advanced software providesunprecedented interactive andprogrammable data analysis capability:• 17 mathematical functions for

processing spectra that you cancombine in any sequence

• flexible use of any number of single ormultiple wavelengths, or average arange of values

• evaluation using user-enteredequations, single-component or multi-component analysis

• up to four different types of dataanalyses performed on one set of data inparallel

• use confirmation analysis withquantitative methods to check theidentity and purity of samples, and todetect if measurements are being madeoutside the linear range of the analysis

Virtually every aspect of the system canbe customized through macroprogramming.

The challenge

Provide a powerful and flexible UV-visiblespectroscopy system for the methoddeveloper with easy transfer of thedeveloped methodologies to routinelaboratory systems.

S o l u t i o n s f o r r e s e a r c h a n d m e t h o d d e v e l o p m

Method development tools

Four special utilities are provided to assistthe user in developing the bestparameters for quantitative analysis:• Evaluate Standards for linearity –

performs a single component calibrationat each wavelength over a user-specified wavelength. It determines thecorrelation coefficient and uncertaintyat each wavelength.

• Compare Calibrations – puts the resultsfrom two independent calibrations sideby side on the screen for comparison.

• Optimize Wavelength for selectivity andaccuracy – quantifies a user-selectedsample at all wavelengths and plots thequantification results againstwavelength.

• Test Method for precision – calculatesthe average and standard deviation ofmultiple analyses of an identicalsample.

Report Customization

A series of predefined reports areavailable in the software. However, tofulfill specific needs, the user can definetheir own customized reports based onthe predefined reports or user definedtemplate.

The solution

Add the advanced software to the AgilentChemStation system to provide specialdevelopment tools and powerful analysisand automation capabilities.

e n t

automation processes that you develop onthe advanced system can be transferredto and executed on the general purposesystem.

Electronic records and signatures

The advanced mode can be combinedwith the security pack to support 21 CFRpart 11.

The Optimize Standardsfunction shows thewavelengths that givethe best calibration

Multi-componentanalysis with diagnostic

tools that show thequality of the results

”Thepower and

flexibility to developthe optimum method

and solve thetoughest

problems”

Ease of use

The dissolution testing software builds onthe Agilent ChemStation platform. Itprovides the additional tasks that arerequired for data evaluation and reportingand uses the same easy-to-use pictorialuser interface.All parameters necessary to perform adissolution test are stored in a singlemethod file. Methods include proceduresthat guide the operator through thespecified tasks.

Real-time display

During the dissolution test you get fulloverview of the system and bath statusand the progress of the dissolutionprocess. The graphical profile displayshows in real-time the progress in allvessels. A numeric display shows you theactual values for each vessel at themeasurement time as well as the averageand statistics. A spectral window alwaysshows all spectra of the last cycle.

Integration of third-party equipment

The open architecture of the third-partyinterface allows integration of bathsthrough Dynamic Data Exchange (DDE).Major bath manufacturers provide thenecessary drivers to allow control of thebaths through Agilent ChemStation. Dataacquired from the baths are also includedin the common result file and final report.For fully automated dissolution testing thesystem can be combined with automationsystems such as the MultiDose dissolutionworkstation from Zymark Corporation.

Calculations and reports

Dissolution results are calculated in real-time and reported based on differentoptions. The software can compensate forvolume changes caused, for example, bypH change, sampling or evaporation. Thisvolume change function can be used toallow processing of dissolution data fromthe flow-through and ”Biodiss”apparatuses (USP 3, 4).Reports are based on a variety ofpredefined templates and include all GLPrelevant information such as operator,date, calibration, and dissolution bathresults. To adapt the report to yourspecific needs the report layouter can beused to create custom report formats.

The challenge

Provide an easy-to-use, flexible, andproductive dissolution testing system forformulation development and QA/QC.

S o l u t i o n s f o r d i s s o l u t i o n t e s t i n g

Good Laboratory Practice

The dissolution testing software featuresspecific tools for dissolution testing tohelp to comply with GLP regulations suchas user defined pre- and post- dissolutionsequences:• users can load only those methods for

which they have permission• flow rate check of pump• transfer of bath parameters to the bath• wash cycle to clean the tubing• remeasure standard• measure control for a system suitability

test• medium test

Standards and samples are measuredand stored in the result file as full spectrafor positive sample identification andproof of purity. In the rare case ofsomething going wrong, the availability ofall sample spectra is also very useful andcan shorten an investigation dramatically.All method parameters (meta data) aswell as different logbooks are also storedin the result file for completedocumentation and reprocessingcapabilities from a single source.In addition, all features are availablewhich are built in the verification anddiagnostic software.

Electronic records and signatures

The dissolution testing mode can becombined with the security pack tosupport 21 CFR part 11.

The solution

Add the dissolution testing software to theAgilent ChemStation system to providethe specific data evaluation and samplingsystem control.

High-throughput QA/QC dissolution testing on up tofour baths simultaneously

The run-time display shows profiles, actual valuesand the last spectra as well as the status ofinstrument at a glance

The user-defined sequence guides the operatorthrough the tasks done before a dissolution run

”The mostflexible and

adaptable systemfor formulation

development androutine testing”

Offline dissolution testing

In offline dissolution testing the samplesare collected independently from theanalytical system. These samples aremeasured by the Agilent 8453 UV-visibledissolution testing system using standardcells or, for more convenience, with asipper. In both cases the operator isprompted for the specific sample. Forunattended operation an autosampler canbe used. In all cases the sampling forblank, sample and control, is userdefinable.

Online dissolution testing

In online dissolution testing the samplingis done automatically direct from thedissolution bath under control of thedissolution testing system. Choose amulticell or a valve-based sampling

The solution

The Agilent 8453 UV-visible dissolutiontesting system controls the whole rangeof sampling systems, from manual to fullyautomated.

system. For high-throughput QA/QCdissolution testing up to four baths can besampled from one Agilent 8453 dissolutiontesting system.

Multicell-based sampling system

The multicell system is the mostcommonly used sampling system withsingle bath testing. It uses a multicelltransport with eight flow cells, one for theblank, up to six for the individual vesselsand one for a control, and a multi-channelpump to sample all vesselssimultaneously. A minimum cycle time oftwo minutes is possible. The dissolutionmedium is recycled so that there is nochange in medium volume during the test.This system is the most versatile one andideally suited for low volume QA testingas well as formulation development.

S a m p l i n g s y s t e m s

Valve-based sampling system

The valve-based system is the most cost-effective solution. It uses an eight-portvalve to switch between blank, controland the six dissolution vessels, and has asingle channel to transfer the sample.Because the sampling is sequential, theminimum cycle time is five minutes. Ateach sampling cycle a small volume(about 4 ml) of dissolution medium is lostbut the software can correct for this lossduring calculation of the results.

Multi-bath sampling for increasedproductivity

When you have large numbers of samplesto analyze the Agilent 8453 dissolutiontesting system in combination with thevalve-based, multi-bath sampling systemgives you the highest productivity. Thesystem can measure a blank, six vesselsand a control in up to four baths all withinfive minutes. On each of the baths anindividual method can be used. Themethods and features are identical aswith the single-bath, valve-based system.

The challenge

Provide an easy-to-use, flexible, andproductive dissolution testing system forformulation development and QA/QC.

Single-bath valve-sampling system

Dissolution vessels

Waste Control Blank

Valve/pumpcontroller

Valve

Pump

”Scaleablesampling frommanual offline

through fully auto-mated online

(with up to fourbaths)”

Single-bath multicell-based sampling system

Multi-bath dissolution sampling system

Waste

Dissolution vessels

4 pumps Multicelltransport

Control Blank Control Blank Control Blank Control Blank

Multicell transport

Multichannel pump

Blank Control

Tungsten lampDeuterium lampLensShutterLensSlitGrating1024-elementdiode array

A g i l e n t 8 4 5 3 U V - v i s i b l e s p e c t r o p h o t o m e t e r

The Agilent 8453 UV-visible spectro-photometer offers the latest in diode-arraytechnology:

• compliance with all requirements of theEuropean Pharmacopoeia (EP) andUnited States Pharmacopeia (USP)

• small footprint to save bench space• prealigned deuterium and tungsten lamp

light sources for trouble-freemaintenance

• built-in buttons to measure sample,standard, and blank for convenientmeasurements even when wearinggloves

• thermally stable ceramic spectrographfor a wide operating temperature range

• communication through GPIB or LAN fordedicated or networked PC control

• firmware upgrade from PC for easyparticipation in future developments

• built-in GPIO interface for control ofaccessories

Agilent 8453 optics

Good Laboratory Practice

The Agilent 8453 supports compliancewith GLP regulations:

• serial and firmware revision numberheld in firmware

• own clock for time and date stamps ofthe spectra

• extensive self-test procedures thatcheck the electronics and key opticalcharacteristics to ensure consistentperformance between validation

• built-in electronic logbooks whichcontain the results of self tests, notes oninstrument

• maintenance, events and errors

Optical performance

The Agilent 8453 offers the advantages ofa diode array plus significantimprovements in optical performance:

• 190–1100-nm wavelength range• 1-nm slit width• <0.03 % stray light

The diode-array advantages

Backed by over two decades ofexperience in the development andmanufacture of diode-arrayspectrophotometers, the Agilent 8453gives you clear advantages.

• Fast spectral scanning for completespectral information useful for:• Proof of identity and pureness of the

sample• Additional information for “out of

specification test result” investigationin a regulated environment

• Re-evaluation with different method• Multi-wavelength applications such as

user-defined equations• Open sample area for convenient

sample handling.• High throughput optics guarantees

excellent signal-to-noise for highsensitivity.

• Virtually absolute wavelengthresettability allows selection of optimumwavelength and use of electronicstandards.

• Exceptional ruggedness and reliability.

Sipper operation is easy with built-inmeasurement buttons

Side door for easy lamp change

Optical performance

Wavelength range 190–1100 nm

Slit width 1 nm

EP resolution test >1.6 toluene in hexane, ratio abs. at 269 nm/266 nm

Stray light <0.03 % at 340 nm (NaNO2, ASTM)<0.05 % at 220 nm (NaI, ASTM)<1 % at 200 nm (KCl, EP)

Wavelength accuracy <±0.5 nm 0.5-second scan (NIST 2034)<±0.2 nm at 486.0 and 656.1 nm

Wavelength reproducibility <±0.02 nm ten consecutive scans (NIST 2034)

Photometric accuracy <±0.005 A at 440.0, 465.0, 546.1, 590.0, and 635.0 nm, 1 A (NIST 930e)<±0.01 A at 235, 257, 313, 350 nm, at 1 A (potassium dichromate,

EP method)

Photometric noise <0.0002 A sixty 0.5-second scans at 0 A, 500 nm, rms

Photometric stability <0.001 A/h at 0 A, 340 nm, after 1-hour warm up, measured over 1 hour,every 5 seconds, constant ambient temp.

Baseline flatness <0.001 A 0.5-second blank, 0.5-second scan, rms

Typical scan time 1.5 second full range

Shortest scan time 0.1 second full range

Time until next scan 0.1 second full range, 0.1-second scan, up to 150 consecutive scans

Physical dimensions

Height × width × depth 185 × 344 × 560 mm (7.3 × 13.5 × 22.0 inches)Weight 16.5 kg (36.3 lb)

Power requirements

Line voltage 90–264 V ACLine frequency 47–63 HzPower consumption 70 VA typical

Environmental conditions

Operating temperature 0–50 °C (32–122 °F)Non-operating temperature -40–70 °C (-4–158 °F)Humidity <95 %, at 25–40 °C (77–104 °F)

Specifications – Agilent 8453 UV-Visible spectrophotometer

The ceramic chassis used in the Agilent 8453spectrophotometer is manufactured under licensefrom Carl Zeiss.

Open sample area means large accessories areeasy to use–here the Peltier cell holder

Spectrum of a 0.02 % v/v solution of toluenein hexane

Cell holders

Agilent Technologies offers a range ofsingle cell holders, providing you with theability to analyze a wide variety ofsamples. Unless otherwise stated theholders accept cells with path lengths upto 10 mm.

Standard cell holder: Ensures quick andprecise cell positioning for eachmeasurement. Supplied standard with allAgilent Technologies spectrophotometers.

Thermostattable cell holder: Whenconnected to a circulating-water bath,ensures constant sample temperature fortemperature-sensitive analyses. Anoptional accessory provides water-drivenstirring with magnetic stirring bar for10-mm cells.

Long-path cell holder: Holds rectangularand cylindrical cells with path length upto 100 mm.

Multicell transport

The multicell transport provides asignificant increase in productivity whenyou need to do simple, repetitivemeasurements on a small number ofsamples, or when you want to followchanges in several samples (for example,enzyme kinetic studies). The multicelltransport features:• full control through software,• eight cell positions (for example, one

blank and seven samples),• random access to all positions,• water thermostattable using external

water bath, 5–90 °C temperature rangeand ±0.3 degrees temperature differencebetween any two cells at 37 °C,

• <1 second to move between adjacentcells, and

• ±0.1 mm position repeatability.

Peltier thermostatted cell holder

Use the Peltier controller and cell holderwhen you require precise or variabletemperature control:• built-in magnetic stirrer,• heat exchanger for sample pre-heating

when using a sipper system,• fully controlled through software and

GPIB interface,

A c c e s s o r i e s

• external sensor for precise sampletemperature (optional),

• typical range of 10–100 °C (-10 to +80degrees relative to ambient) withoutneed for water cooling,

• accuracy of ±0.2 degrees at 20–40 °C,±0.3 degrees at 0–20 °C and 40–60 °C,±0.5 degrees at 60–100 °C,

• reproducibility of ±0.1 degrees at0–60 °C, ±0.2 degrees at >60 °C, and

• stirrer speed of 40–1000 rpm.

Sipper system

For repetitive measurement of liquidsamples a sipper system improvesproductivity and eliminates errors causedby manual cell handling. The Agilentsipper system comprises a peristalticpump and a quartz flow cell:• full control through software,• variable pump, delay, and return time,• flow cell with 10-mm path length, 3-mm

diameter, and 80-µl volume,• constant-speed peristaltic pump with

Tygon pump tubing,• minimum sample volume of

approximately 1 ml, and• typical sampling time of 20 seconds

(with <1% cross-contamination).

Autosampler

Combine an XY autosampler with a sippersystem and you can measure largenumbers of samples fully automatically inunattended mode. The XY autosamplerfeatures:• full control through software,• capacity of up to 240 samples,• wash station for optional rinsing

between samples,• 10–13-mm diameter sample tubes with

maximum height of 100 mm,• typical transit time (adjacent samples) of

approximately 6 seconds (includingraising and lowering probe),

• typical time per sample of 25 seconds(including sipper operation time), and

• minimum sample volume of 2 ml.

Cells

Agilent Technologies offers a range ofquartz cells for standard and flow-throughoperation including:• Regular rectangular cells with path

lengths of 1, 2, and 10 mm.• Cylindrical cell with 100-mm path

length.• Stoppered cells to protect your sample

from air and ideal for use with theexternal sensor of the Peltiertemperature controller.

• Flow cells with rectangular, oval orcircular apertures with screw fittingsand path lengths of 1, 2, 5 and 10 mm.

• Semi-micro and micro cells with pathlengths of 2 and 10 mm for minimumsample volumes of 15 and 60 µlrespectively.

For more details see the AgilentTechnologies Columns and SuppliesCatalog.

Third-party accessories

A wide range of accessories, designed foror compatible with Agilent Technologiesspectrophotometers are available:• Gilson autosamplers that are controlled

directly from the Agilent TechnologiesChemStation software,

• Labsphere diffuse reflectanceaccessories,

• Applied Photophysics stopped-flowaccessory for fast kinetics,

• Hi-Tech stopped-flow accessory for fastkinetics,

• Distek dissolution baths, and• Zymark MultiDose dissolution

workstation.

Ask your Agilent Technologiesrepresentative for more details.

Agilent Technologies support

Agilent Technologies has support centersin 85 countries supplying a wide range ofsupport products that can be tailored toyour needs.

For example, the Agilent Technologiesnetwork of Analytical Response Centersprovides direct access to supportprofessionals who help you resolveoperational difficulties, and offerassistance and advice on running AgilentTechnologies chemical analysis software.They also help you to solve analyticalproblems, to keep your equipment up todate, and to maintain GLP standards.

All of us at Agilent Technologies are hereto help you meet your chemical analysisgoals, not just now but also long into thefuture.

Sipper pump

Selection of software modules

Adapt the 8453 spectroscopy system toyour needs by adding different softwaremodules to the general-purpose software.One or more modules can be added to atthe same time to support differentapplications.

If you work in a regulated environment,add the security pack software for helpwith compliance to 21 CFR part 11. Pleasenote that for full support of 21 CFR part 11,the advanced and/or the dissolutiontesting software is required. An overviewon the different features is given intable 1.

A g i l e n t ’s U V - v i s i b l e s p e c t r o s c o p y s o l u t i o n s f o r

Increasing productivity

The ChemStation software allows controlof different sampling systems to increasethroughput. A common feature of thegeneral purpose, advanced anddissolution software is that the predefinedmethods work with different samplingsystems – without changing parameters.Therefore, a method developed formanual sampling can easily be used witha sipper or autosampler, depending on theactual demand.

For convenient operation and mediumsample throughput the sipper system isrecommended.A sipper system consists of:

Software mode

Feature Standard Advanced Dissolution Kineticmode mode mode mode

not supported

Raw data protection YES YES YES –

Storage of raw and meta data NO YES YES –

Mandatory log-on YES YES YES –

Versioning on the ChemStation side NO YES YES –

Electronically signing off NO YES YES –

Application lock * YES YES YES –

Audit-trail method YES YES YES –

Audit-trail raw/meta data NO YES YES –

Archiving built-in ** NO NO NO –

Password policy part 11 YES YES YES –

Data recovery tools ** NO NO NO –

* Not mandatory for part 11 compliance but important in production environment.** Not mandatory for part 11 compliance, but highly recommended for the data security andlong-term data storage. These tasks have to be done by the IT department.

Table 1Compatibility of Security Pack software

8453 ChemStation SW

General Purpose

Verification and diagnostics

8453 spectroscopy systemwith standard software

Advanced DissolutionDissolution testingMultibath dissolution testingCombined report

Biochemical Analysis

KineticsThermal denaturation

Security Pack

Software modules

Security software modulefor compliance to21 CFR part 11

For unattended operation and highsample throughput, the autosamplersystem is recommended. It consists of:

Sipper pump Autosampler

8453 ChemStation SW

p h a r m a c e u t i c a l a n a l y s i s – a t a g l a n c e

Selecting the dissolution sampling system

For offline dissolution testing, you can adda sipper or autosampler for increasedproductivity.

For online dissolution testing, two kinds ofsampling systems are available, parallelsampling using a multicell transport orsequential sampling using a valve.

Select the valve system if:• upgrade to a multibath system is

planned• only one flow cell should be used• staggered tablet drop is not a problem• budgets are tight

Select the multicell-based system, if• a closed loop system is required• minimum cycle times must be achieved• parallel sampling is required for

automated tablet drop or basketmethods

Microsoft® is a U.S. registered trademarkof Microsoft Corporation.For more information on our products andservices, visit our worldwide web site athttp://www.agilent.com/chem

The information in this publication issubject to change without notice.

© Copyright Agilent Technologies, 2000, 2001

All Rights Reserved. Reproduction,adaptation or translation without priorwritten permission is prohibited, exceptas allowed under the copyright laws.

Printed in Germany, November 1, 2001

Publication Number 5968-8815E