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8453 UV Dissolution System Brochure


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8453 UV Dissolution System Brochure - 1


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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...

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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...

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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...

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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...

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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. •...

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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...

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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...

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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....

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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...

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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. •...

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