Cecil Dissolution 4/9/06 4:51 pm Page 1 DISSOLUTION SYSTEMS

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1 DISSOLUTION SYSTEMS

2 CE 3790 Dissolution Tester Cecil Instruments offer complete dissolution systems as well as all the components of the system individually. The dissolution tester is common to the systems and may be used in conjunction with a choice of spectrophotometers. It is fully USP, EP and JP compliant. The CE 3790 tester is provided with seven stirred round bottom, graduated, glass vessels; the eighth position is used for stirring the thermostatted water in the perspex bath. The water is heated by a 1000 watt element and the temperature may be set between 30 C and 45 C with an accuracy of ±0.2 C. * The CE3890 is available with 8 stirred vessels. Stirring speed may be set in the range rpm. The stirring head is conveniently pneumatically counterbalanced for easy access to the vessels and paddles for adjustments. The standard paddles are of PTFE with PTFE coated spindles. Provision is made for accurate centring of vessels and paddles, using test gauges, and gauges are provided for stirrer height adjustment. CE 3792 Software - WIN DISS This is a comprehensive dissolution software package for control and data processing, incorporating the following features: Storage for 100 methods; stores stirrer speed, temperature, sampling sequence, measuring wavelength etc. A time run data store for batch number, name, operator ID, calculation details, data correction using run or pre-run blank, media evaporation etc. Calculation details include theoretical maximum absorbance, measured standard concentration, standard measurements using linear regression and standard concentration at known testing times. Results are printed in tabular and graphical form including absorbance data, milligrams or % release and a 95% confidence calculation is provided. The printout may be formatted by the operator. The statistical programme includes batch comparison and Q1-Q3 USP acceptance test. 2

3 CE 7260 Spectrophotometer This symmetrical double beam spectrophotometer from the Aquarius series, with an 8 cell changer, has a 1.8nm optical bandwidth and is ideal for dissolution measurements. Its stability of, ±1 x 10-4 A/hour, approximately ten times better than single beam instruments, makes it ideal for extended measurements such as sustained release monitoring. Full cell and wavelength programming together with wavelength scanning make the instrument ideal for dissolution applications and may, when required, be used as a high quality scanning double beam spectrophotometer for other applications. Operation is simple following menus and prompts displayed on the LCD screen, using the keypad to interact with the comprehensive embedded software. Validation software is available. Used in System 1. CE 9260 Spectrophotometer This is a top performance double beam spectrophotometer from the Super Aquarius Series. The optical system is fully symmetrical and uses a high performance end window photomultiplier as detector. This ensures the very best performance with minimum drift and the best possible noise performance, particularly for low energy conditions. Both method and spectral scan storage are provided together with powerful software for all applications. For top performance this is the instrument of choice. Validation software is available. Used in System 3. CE 3021D Spectrophotometer This is a high quality single beam spectrophotometer from the Super Aurius series, with an 8 cell changer and 1.8nm optical bandwidth. Its stability of 1 x 10-3 A/hour makes it suitable for dissolution monitoring, and may be used as a general purpose or scanning spectrophotometer if required. Full wavelength and cell programming, as well as wavelength scanning, are possible. Operation is via embedded software using an LCD screen to display menus, prompts etc. with entries made through its comprehensive keypad. Enhanced accuracy is provided, as with the CE 7260, by the very low, 0.01%, straylight. Software for validation is available. Used in System 2. CE 3791 Peristaltic Pump The CE 3791 is a multi-cartridge design with good flow accuracy. Each of the eight channels may be individually released, or adjusted for roller operating pressure. The pictures shown here are of the pump with flow tubes and the pump with one of the cartridges in the released position. 3

4 Double Beam System Shown here is the dissolution tester used with the CE 7260 double beam spectrophotometer; this forms the basis from which dissolution System 1 is formed. The compact tester and spectrophotometer occupy only a small amount of bench space. The tester has 7 stirred sample vessels, the eighth position is used for circulation of the water, heated by a 1000W element. The system and data collection are controlled by the CE 3792 WIN DISS software which can be installed in most available PC s. Sample Compartment The sample compartment of the CE 7260 spectrophotometer is shown with the eight cell automatic changer fitted. As shown, a reference cell may be accommodated in the reference beam. The instrument is fitted with a light-tight port through which all the sampling tubes pass for connection to the flowcells. Automatic Cell Changer The cell changer is shown here removed from the instrument and fitted with its eight cell holder. Fitting the changer to the instrument is simple and rapid, as is fitting the flow tubes to the flow tube port. The same changer is used with the CE

5 Single Beam System This picture shows the CE 3790 dissolution tester coupled to a CE 3021D single beam spectrophotometer. The small size of the spectrophotometer coupled with the compact design of the tester lead to a system requiring only the minimum of bench space. This combination is the basis from which System 2 is formed. The system uses the same CE 3792 WIN DISS software used by the double beam system 1, collecting data and providing system control. Also the tester provides 7 stirred vessels with the eighth position used for circulating the temperature controlled water, heated by a 1000W element. Sample Compartment The eight cell auto-changer is shown here in position in the single beam spectrophotometer. The compact compartment accommodates the holder fitted with its eight cell changer in a convenient fashion, with all the sampling tubes passing through the special flow tube port. Automatic Cell Changer The compact and convenient to use eight cell changer is shown here, fitted with the eight cell holder, before fitting to the instrument. The flow tubes are tidily guided to the flowcells from the flow tube port fitted to the instrument. 5

6 Dissolution Tools A full range of tools is available for USP methods 1, 2 and 6. These include baskets in stainless steel, or gold plated, and paddles in stainless steel, or Telfon coated. Rotating cylinders are available, and devices for Transdermal studies of gels, suspensions and ointments. Dissolution Baskets Dissolution baskets are available in a range of mesh sizes to meet most requirements. Mesh sizes of 10, 40 and 100 mesh grades are available in standard form or gold plated. Capsule Sinkers These devices, ideal for formulations which will not sink under gravity, are made from stainless steel with snap tight closures and conform to Japanese Pharmacopoeia Specifications. Depth Gauges These devices allow rapid and accurate setting of the stirring tool depth, and also vessel centring with a centring option. The devices simply snap onto paddle or basket tools. Wobble Tester This tester, consisting of a spindle mounted dial gauge, enables any rotational wobble of the dissolution tool in its vessel to be measured and adjustments to be made to give less than ±0.2mm wobble. Mesh Discs For paddle over disc methods, (USP method 5), two sizes of mesh disc are available, 35 and 85mm diameter, which fit directly into standard dissolution vessels. Dissolution Vessels Graduated dissolution vessels, in clear glass, are available in standard or certified form. Vessels are numbered and specifications are to the USP standard. UV resistant amber glass vessels are also available. 6 Manual Sampling A syringe system is available for simple and effective manual sampling from dissolution vessels and can be supplied with either a 5, or 10 micron filter.

7 CE 3790 Tablet Dissolution Tester Supplied complete; includes 7 graduated round bottom vessels, 7 plastic covers for vessels, perspex water bath mounted on a stainless steel base, polycarbonate bath cover, water heating coil, water circulation stirrer, drive head with pneumatically assisted lifting system. 7 PTFE paddles with coated shafts, connecting cable to PC, stainless steel sample tubing set, 2 sets silicon tube for peristaltic pump, set of tygon tubing for connecting to pump and from pump to spectrophotometer, immersion depth gauges. CE 9260 Double Beam Spectrophotometer nm wavelength range, 1.8nm optical bandpass, dissolution sample compartment with flow tube port, 8 position cell changer, 8 cell holder, power cable, cable to PC and operators manual. CE 7260 Double Beam Spectrophotometer nm wavelength range, 1.8nm optical bandpass, dissolution sample compartment with flow tube port, 8 position automatic cell changer, 8 cell holder, power cable, cable to PC and operators manual. CE 3021D Single Beam Spectrophotometer nm wavelength range, 1.8nm optical bandwidth, dissolution sample compartment and lid, flow tube port, 8 position cell changer and cell holder, power cable, cable to PC and operators manual. CE 3791 Peristaltic Pump Eight channel variable speed peristaltic pump. CE 3792 Dissolution Software For dissolution system control and data processing. ORDERING SYSTEMS For convenience of ordering, Pharma Quest systems are offered which contain all the items required to assemble a working system and commence operation when flowcells and a PC with the appropriate specification are added. System 1: System 2: With Double Beam Spectrophotometer. CE 3790, CE 7260, CE 3791, CE 3792 and all items to complete the system. Requires flowcells and a PC. With Single Beam Spectrophotometer. CE 3790, CE 3021D, CE 3791, CE 3792 and all items to complete the system. Requires flowcells and a PC. System 3: With Double Beam Spectrophotometer. As System 1, with CE 9260 Super Aquarius spectrophotometer instead of the CE 7260 Aquarius spectrophotometer. Alternative Dissolutions Systems Systems may be based on the top of the range Super Aquarius double beam spectrophotometers CE 9260 and CE The CE 9560 is a variable resolution instrument with band width selectable from 0.5nm to 4nm and the CE 9260 has a fixed bandwidth of 1.8nm. Both instruments have a photomultiplier detector and superb overall performance. Both of these instruments use the same automatic 8 cell changer and holder that is used in the Aquarius CE ORDERING ACCESSORIES AND SPARES Flowcells - UV Grade Silica 1mm pathlength mm pathlength mm pathlength mm pathlength Flowcells - Optical Glass 1mm pathlength nm pathlength mm pathlength mm pathlength Spectrophotometer Spares Deuterium lamp Tungsten halide lamp (in pairs) Fuse kit for CE Fuse kit for CE3021D Vessels and Stirrers Graduated 1L clear glass vessel; certified Graduated 1L brown glass vessel; certified PTFE paddles and coated stirrers, batch coded, set Stainless steel paddles and stirrers, batch coded, set Depth gauge for paddle stirrers Capsule sinker set, stainless steel Spindle with basket set; 10 grade mesh stainless steel Spindle with basket set; 40 grade mesh stainless steel Spindle with basket set; 100 grade mesh stainless steel Mesh disk set, 35mm diameter (USP/5) Mesh disk set, 85mm diameter (USP/5) Manual sampling syringe system Plastic cover for vessels Cover insert for water circulator position Stirrer shaft plastic adjustment screw Tubing and Filters Silicone tube kit for pump Tygon tube installation kit Sintered filters - 10 micron (50 pcs) Stainless steel sampling tubes and connectors set Calibration Stirrer wobble gauge, mounted Opto-electronic tachometer Digital thermometer and sensor; calibrated

8 CE 7260 Aquarius and CE 7460 CE 3021D Super Aurius Optical System Symmetrical double beam Single beam Monochromator Czerny Turner; 1200 line/mm grating Littrow, 1200 line/mm grating Wavelength Range CE nm nm CE nm Wavelength Accuracy 0.5nm 1nm Wavelength Reproducibility Optical Bandwidth Straylight 0.1nm 1.8nm; 1nm option for CE7460 Typically less than 0.01% at 220nm and 340nm Stability Better than A/hour Better than 0.001A/hour Photometric Range to 3A Photometric Accuracy ±0.004A at 1A The greater of ±0.005A or 1% Cell Program Method Storage Wavelength Program Wavelength Scanning Computer/Printer Interfaces Power Requirements For up to 8 cells For up to 30 methods, password protected For up to 10 wavelengths Up to 4000nm/min Bi-directional serial RS232 and parallel ports 110V-250V, 50/60Hz, 170W Size and Weight 635 x 410 x 210mm, 35kg 480 x 340 x 205mm, 18kg The CE 9260 Super Aquarius spectrophotometer is a top performance spectrophotometer equalling or exceeding the specification of the CE 7260 in all respects. Dissolution Tester Specification Number of Stirred Vessels 7 - CE 3790; 8 - CE 3890 Stirrer Tools Paddles, baskets and cylinders Water Bath Heater 1000W; with stirrer Stirrer Speeds rpm Stirrer Speed Accuracy ± 1 rpm Stirrer Wobble Less than ± 0.2mm Bath Temperature C Temperature Accuracy ±0.2 C Interface RS232 Bath Temperature LED display Stirrer Speed LED display Stirrer Head Opening Pneumatically supported Minimum Computer Specification Pentium 200MHz or better Microsoft Windows 98 or better Microsoft NT 4.0 with service pack 3 or later 64 MB of RAM or more Hard disk space required : 15MB CD-ROM drive XGA or higher resolution monitor Monitor resolution 1024 x 768 or better Cecil Instruments policy is one of continuous development. We therefore reserve the right to change specification without notice. CECIL INSTRUMENTS LIMITED MILTON TECHNICAL CENTRE CAMBRIDGE CB24 6AZ ENGLAND ISO 9001 : 2000 TELEPHONE: FAX: CERTIFIED COMPANY info@cecilinstruments.com WEB SITE: