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Semi Automated Dissolution Testing for USP method 4

With the Flow-Through Cell, fresh media passes continuously across the dosage form. This is called an open loop system. A semi-automated system allows samples to be taken simultaneously and collected in a fraction collector or analysed directly by UV. Complete fractions or aliquot’s can be collected in an Off-line open system. It is also possible to collect samples and analyze them. Dissolution can also be analysed in situ in a Fiber Optics Dissolution system also called UVFO.

USP 4 Fixed and Small Volume Dissolution/Elution Testing...For small or fixed volume testing, the flow through cell can re-circulate the media across the dosage form. This is called a closed loop system. This can be an on-line closed loop with UV or UV Fiber Optic, micro volume autosampler, and even a manual sampling syringe.

SOTAX CE 7smart OFF–LINE CLOSED SYSTEM

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Custom-designed off-line closed dissolution system for dissolution tests according to the Flow-Through Method (USP 4) with sample collection for all dosage forms

» Designed for R&D and QC
» Driven by firmware
» Specially adapted to small volumes work e.g. Drug Eluting Stents methods
» Syringe module allowing accurate sampling down to 150 litres
» 29 rows of sampling without carry-over
» Direct collection in closed HPLC vials
» Can be upgraded to double off-line to test 14 samples
» Piston pumps CY7-50 or CP7-35 to get optimal results from a compliant system

SOTAX CE 7smart OFF–LINE OPEN SYSTEM

Custom-designed off-line open dissolution system for dissolution tests according to the Flow-Through Method (USP 4) with sample collection for all dosage forms with easy media and/or pH changes for simple in-vivo simulation;

» Designed for R&D and QC
» Fully controlled by firmware
» Direct collection in tubes or HPLC vials
» Designed for open loop with splitting valve
» Piston pumps CY7-50 or CP7-35 to get optimal results from a compliant system
» pH change through media selector

SOTAX CE7smart USP 4 ON-LINE OPEN SYSTEM

Custom-designed on-line dissolution system for dissolution tests according to the Flow-Through Method (USP 4) with integrated online analysis for all dosage forms with easy media and pH changes for accurate in-vivo simulation

» Designed for R&D and QC
» Fully controlled by 21 CFR part 11 compliant WinSOTAX software
» Direct sample on-line analysis with different possible UV-Vis spectrophotometer types
» Works in a closed loop or open loop with splitting valve
» Standard monitoring, placebo subtraction, multi-wavelength and scan ability (depending on spectrophotometer brand)
» Variable pathlength 0.1 to 10 mm (up to 50 mm depending on the spectrophotometer brand)
» pH change in open loop during the test automatically with a media selector
» Piston pumps CY7-50 or CP7-35 to get optimal results from a compliant system.

FOR MORE INFORMATION PLEASE CONTACT carolmooney@jenesis.ie