Fully-automatic dissolution tester CE 7smart UV Online

for tabletsfor in-vitro drug releaselaboratory

Short description
Flow-through cell dissolution testing system with integrated UV-Vis analysis for real-time measurement of dissolved API. The integrated spectrophotometer measures samples as they are generated, enabling rapid, traceable dissolution results suitable for formulation development, IPC and QC workflows.

Benefits

• ANALYZE – View dissolution profiles in real time to reduce analysis time and accelerate decision making
• ADAPT – Reproducibly test APIs, oral, topical, parenteral and subcutaneous dosage forms
• PROGRAM – Centralize methods and specifications on a validated platform using WinSOTAX®plus
• TEST – Execute dissolution profiles with programmable time points, flow rates and media changes with full traceability
• RECORD – Maintain audit trail, user rights management and unlimited method/reporting capabilities

Highlights
Immediate results for immediate release
The integrated spectrophotometer with multi-cell changer enables near-instant measurement of each vessel as samples are produced. The CP pump fills flow cells connected to dissolution vessels and the spectrometer selects the appropriate cell for measurement, minimizing delay between sampling and analysis. Compatibility with multiple UV-Vis brands and configurations is supported.

From API to novel dosage forms
The CE 7smart expands compendial dissolution testing to cover APIs, intermediates and final dosage forms, providing data from pre-formulation and characterization through IPC and QC testing.

Biorelevant methods
Designed to better mimic in vivo conditions than beaker methods, the flow-through cell technique supports biorelevant media (level 0–3) and on-the-fly pH changes for extended and delayed-release testing. Suitable for poorly soluble compounds (BCS II and IV).

Volume flexibility
Adaptable to open or closed configurations to meet solubility and sensitivity requirements. Media volume can be adjusted from 50 to 5000 mL while maintaining consistent hydrodynamics and reproducible dosage form positioning in the cell.

Evaluating subcutaneous injectables (BioJect™)
BioJect is a specialized flow-through cell for subcutaneous injectables using an agarose hydrogel reservoir to control pore size and diffusion; internal diameter 22.6 mm, enabling assessment of peptide and depot formulations.

Modules and software

• Integrated UV-Vis spectrophotometer with multi-cell changer for online measurement
• CP pump to fill flow cells and enable online sampling
• Software: WinSOTAX®plus for method management, results and reporting (21 CFR Part 11 capable as described in product materials)

Technical specifications

• Model: CE 7smart (UV Online configuration)
• Technique: Flow-through cell dissolution (USP 4)
• Online analysis: Integrated UV-Vis spectrophotometer with multi-cell changer
• Pump: CP pump for flow cell filling and online sampling
• Supported media: Biorelevant media levels 0 to 3
• Volume range: 50 mL to 5000 mL (open and closed settings)
• Dosage forms: APIs, oral, topical, parenteral, subcutaneous injectables (with BioJect cell)
• BioJect cell: 22.6 mm ID, agarose hydrogel reservoir for controlled pore/diffusion characteristics
• Traceability: User rights administration, audit trail, unlimited method programming and reporting
• Software: WinSOTAX®plus for method/result/report management