Product/Service

USP 4 Flow-Through Dissolution Systems

Source: SOTAX Corporation
The Sotax USP Apparatus 4 Flow-Through Cell Dissolution Systems are designed to overcome potential challenges linked to method development for a variety of dosage forms. The USP 4 Dissoltuion Testing Systems are a market leader in method development and feasibility studies, automated sampling, on-line real time analysis, UV Fiber Optic, and customized solutions for unique drug delivery systems.

USP 4 Flow-Through Cell Dissolution Systems

The CE 7smart Flow-through Dissolution Cell Tester uses a USP 4 method in which a a test sample is placed in a specially designed cell through which media is pumped at 37°C. The eluate is filtered upon leaving the cell and can then either be analyzed by UV/UVFO or collected for HPLC. The type of cell is chosen to suit the dosage form and it is permanently maintained at 37°C in a water jacket. Parameters such as flow rate, quantity of dissolution media and filtering porosity are defined during method development.

The CE 7smart Semi-automated USP 4 systems have three available models: USP 4 On-line system, USP 4 Off-line Closed system, and USP 4 Off-line Open system.

The CE 7smart USP 4 Semi-Automated On-line System has integrated online analysis for all dosage forms with easy media and pH changes for accurate in-vivo simulation. It is designed to work in a closed loop or open loop with splitting valve and has direct sample on-line analysis with different possible UV-Vis spectrophotometer types. The USP 4 On-line system has standard monitoring, placebo substraction, multi-wavelength and scan ability.

The CE 7smart USP 4 Semi-automated Off-line Closed System for dissolution tests with sample collection for all dosage forms. The USP 4 off-line system specially adapts to small volumes work methods, and uses a piston pump CY7-50 or CP7-35 to get optimal results from a compliant system. The off-line closed systems has syringe maodule allowing accurate sampling down to 150 µlitres.

The CE 7smart USP 4 Semi-automated Off-line Open System for dissolution tests with sample collection for all dosage forms with easy media and/or pH changes for simple in-vivo simulation. The USP 4 on-line system is designed or open loop with splitting valve, has direct collection in tubes or HPLC vials, and piston pumps CY7-50 or CP7-35 to get optimal results from a compliant system.

USP 4 Flow-Through Cell Dissolution Systems