8453 UV Dissolution System Brochure

8453 UV Dissolution System Brochure
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8453 UV Dissolution System Brochure

Product catalog summary
Overview
The Agilent 8453 UV Dissolution Systems integrate dissolution testing with UV-visible analysis using advanced diode array technology. This system combines Agilent's dissolution instrumentation with ChemStation software and the 8453 UV-visible spectrophotometer, offering ease of use, real-time display, and scalable solutions for various workflows.
Ease of Use
The system utilizes Agilent's ChemStation platform, providing automated sampling, data evaluation, and reporting through a user-friendly interface. All necessary parameters for dissolution tests are stored in a single method file, guiding operators through specified tasks.
Real-time Display
During tests, users can monitor system status and dissolution progress in real-time. The graphical profile display and numeric display provide detailed insights into each vessel's status, including average and statistical data.
Scalable Solutions
The system supports both offline and online solutions, allowing for cost-effective analysis of samples from multiple dissolution apparatus. Online systems can sample from up to four apparatuses using a single spectrophotometer.
Calculations and Reports
The software compensates for volume changes due to pH changes, sampling, or evaporation, supporting data processing from USP Apparatus 3 and 4. Various report templates are available, including GLP-relevant information.
Good Laboratory Practice (GLP)
The software includes tools to comply with GLP regulations, such as user-defined sequences, flow rate checks, and system suitability tests. All method parameters and logbooks are stored for documentation and reprocessing.
Enterprise Content Management
Agilent OpenLAB ECM facilitates the management of methods and data across larger entities, supporting electronic records and signatures compliant with 21 CFR Part 11.
Offline and Online Dissolution Testing
Offline testing involves independent sample collection, while online testing uses automated systems for high-throughput analysis. The system supports multicell and valve-based sampling systems for increased productivity.
Agilent 8453 UV-visible Spectrophotometer
The spectrophotometer features diode-array technology, offering a small footprint, easy maintenance, and compliance with EP and USP requirements. It supports GLP compliance with built-in electronic logbooks and extensive self-test procedures.
Optical Performance
The spectrophotometer covers a wavelength range of 190–1100 nm with high accuracy and stability, providing fast spectral scanning and high throughput optics for sensitive analysis.
Good Laboratory Practice and Validation
Agilent ensures GLP compliance through documented procedures and validation before product release. The standards kit supports photometric and wavelength accuracy checks.
Electronic Records and Signatures
The ChemStation software, combined with Windows and the Security Pack, supports electronic records and signatures, ensuring compliance with FDA 21 CFR Part 11.
Data Integrity and Security
Agilent systems ensure data integrity by saving full spectra, even if only a single wavelength is used. Data is annotated with essential details like date, time, and operator information. Result files include raw data, complete methods, and logbooks. Deleted spectra and comments are preserved for review. Data security is enhanced by saving data in checksum-protected binary files, preventing unauthorized modifications.
Audit Trail and Electronic Signatures
The Agilent UV-visible ChemStation automatically generates a run logbook, detailing who and when spectra were measured and processed. Users can sign result files electronically, with signatures stored in a logbook.
Ideal Dissolution Platform
The 708-DS platform offers reliability and reproducibility in dissolution testing, conforming to international standards. It integrates with Agilent and previous Varian or VanKel apparatus, featuring an intuitive interface for easy method setup and apparatus interaction.
Advanced Usage and UV Analysis Integration
The system supports high-throughput sampling and UV analysis, with options for automated dosage delivery and temperature monitoring. It pairs with the 8453 spectrophotometer for automated method parameter control.
Key Features of ChemStation Software
ChemStation software monitors stirring speed and media temperature, sets parameter verification limits, and generates audit trails. It supports all phases of dissolution testing and extends spectrophotometer lamp life with automatic shutdown.
Solutions for General Purpose Tasks
The Agilent 8453 UV-visible spectroscopy system is user-friendly, with a graphical interface and automation features for increased productivity. It supports compatibility with Windows for multitasking and easy report generation.
Solutions for Research and Development
The software offers powerful data analysis with mathematical functions, multicomponent analysis, and method development tools. It supports customization through macro programming and advanced automation for complex measurement sequences.
Accessories and Support
Agilent provides a range of accessories like wash stations, sample tubes, and cell holders. The sipper system and autosampler enhance productivity. Agilent support centers offer assistance and advice to maintain GLP standards.
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Catalog excerpts

8453 UV Dissolution System Brochure-1

Agilent 8453 UV Dissolution Systems DISSOLUTION AND UV-VISIBLE ANALYSIS

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8453 UV Dissolution System Brochure-2

Industry-leading Diode Array Technology Meets Superior Dissolution Apparatus Design Supported by years of development and manufacturing experience, Agilent now offers a dissolution testing solution that marries its dissolution instrumentation with the industry-leading ChemStation software and 8453 UV-visible spectrophotometer. Ease of Use The dissolution testing software builds on the Agilent UV-visible ChemStation platform. It provides the additional tasks that are required for automated sampling, data evaluation and reporting, and applies the same easy-to-use pictorial user interface. All parameters...

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8453 UV Dissolution System Brochure-3

Mode: Dissolution Testing Dissolution Profile Sample Spectra Dissolution Results Table Time Ves_l Ves_Z The run-time display shows profiles, actual values and the last spectra as well as the status of The user-defined sequence guides the operator through the tasks done before a dissolution run Next Cycle: Remain Time: High-throughput QA/QC dissolution testing on up to four apparatus simultaneously Good Laboratory Practice The dissolution testing software features specific tools for dissolution testing to help to comply with GLP regulations such as user defined pre- and post-dissolution sequences:...

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8453 UV Dissolution System Brochure-4

Online Sampling Systems Automated systems with up to four dissolution apparatus Multicell-based Sampling System The multicell system is the most commonly used sampling system with single apparatus testing. It uses a multicell transport with eight ow cells, one for the blank, up to six for the individual vessels and one for a control, and a multi-channel pump to sample all vessels simultaneously. A minimum cycle time of two minutes is possible. The dissolution medium is recycled so that there is no change in medium volume during the test. This system is the most versatile one and ideally suited...

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8453 UV Dissolution System Brochure-5

Solutions For Dissolution Analysis Selection of Software Modules Adapt the 8453 spectroscopy system to your needs by adding different software modules to the general-purpose software. Multiple modules can be loaded to support different applications. Agilent Open- LAB ECM allows you to manage data and methods across large entities. If you work in a regulated environment, add the security pack software for help with compliance to 21 CFR Part 11. Please note that either the ECM Module or the Security Pack can be installed on a UV-visible system, but not both.. Increasing Productivity The ChemStation...

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8453 UV Dissolution System Brochure-6

The Agilent UV-visible Spectrophotometer UV-visible spectroscopy solutions that satisfy the diverse needs of analysts in routine QA/QC, research, and method development laboratories The Agilent 8453 UV-visible spectrophotometer offers the latest in diode-array technology: • Small footprint to save bench space. • Prealigned deuterium and tungsten lamp light sources for trouble-free maintenance. • Built-in buttons to measure sample, standard, and blank for convenient measurements even when wearing gloves. • Thermally stable ceramic spectrograph for a wide operating temperature range. • Communication...

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8453 UV Dissolution System Brochure-7

Specifications – Agilent 8453 UV-Visible Spectrophotometer Optical performance Wavelength range Slit width toluene in hexane, ratio abs. at 269 nm/266 nm Stray light Wavelength accuracy Sipper operation is easy with built-in measurement buttons Wavelength reproducibility ten consecutive scans (NIST 2034) Photometric accuracy Photometric stability at 0 A, 340 nm, after 1-hour warm up, measured over 1 hour, every 5 seconds, constant ambient temp. Baseline flatness Typical scan time full range Shortest scan time full range Time until next scan full range, 0.1-second scan, up to 150 consecutive scans...

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8453 UV Dissolution System Brochure-8

Good Laboratory Practice Easy compliance to GLP for increased productivity Agilent plays a leading role in dening the GLP-related responsibilities of manufacturers and users. And, Agilent implements features in its products that enable users to comply with GLP regulations quickly, reliably, and productively. All you need for Installation Qualication (IQ) and Operational Qualication/ Performance Verication (OQ/PV) is provided for both the spectrophotometer and system software. Full documentation is included and, where appropriate, procedures are supported by software to save time. IQ and OQ/PV...

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8453 UV Dissolution System Brochure-9

Electronic Records and Signatures The Agilent UV-visible ChemStation software in combination with Windows® and the optional Security Pack can be configured to support the requirements for electronic records and signatures for a closed system as defined in FDA 21 CFR Part 11. Tools and products for system installation and operational qualification also complete this Access Control Two levels of permissions are defined and managed by the system administrator as user groups within Windows. All access control features of Windows can be applied such as password aging, uniqueness or account lock. The...

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8453 UV Dissolution System Brochure-10

Better Design, Better Results The 708-DS and 709-DS Dissolution Apparatus is designed to deliver consistent performance and results while minimizing or eliminating external variables affecting the dissolution test. Ideal Dissolution Platform Providing a new standard for reliability and reproducibility in dissolution testing, the rugged 708-DS platform conforms to internationally harmonized pharmacopial standards as well as the mechanical qualication standards from the FDA and ASTM. The drivers work with all new Agilent apparatus, as well as previous Varian or VanKel dissolution apparatus to integrate...

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8453 UV Dissolution System Brochure-11

Key Features of ChemStation Software • Monitor stirring speed and media temperature during the test at specified time intervals, and automatically record this data with the dissolution test results. • Set limits for parameter verification at each timepoint and automatically generate an audit trail to determine out of range parameters. • Utilize ChemStation software in all phases of dissolution testing, including the run and preparation phases, as well as the postrun phase where data results are stored, reports are printed, the sampling system and media transfer channels are cleaned. • Extend...

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