For over 30 years, SOTAX has been developing USP Apparatus 4 Flow Through Cell Dissolution with experts in academia and industry. Today, SOTAX is a worldwide market leader with expertise in method development and feasibility studies, automated sampling, on-line real time analysis, and customized solutions for unique drug delivery systems.
The CE 7smart is the fourth generation of SOTAX flow-through cell systems and has been designed as the Apparatus 4 instrument made to overcome potential challenges linked to method development for a variety of dosage forms.
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 analyzed directly by UV. Complete fractions or aliquotes can be collected in an Off-line open system. It is also possible to collect samples and analyze them.
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, micro volume autosampler, and even a manual sampling syringe.
The validation of the USP 4 Dissolution Testing system according to the regulations can be done by a SOTAX specially trained service engineer. The USP requires the flow rate and temperature to be qualified.