CE 7smart紫外在线分析
集成实时样品紫外-可见光分析功能的流池法溶出度测试系统。
- 分析 - 溶出測试结果可实时查看，有效缩短分析时间并降低成本
- 适应性 - 可重复测试活性成分、口服、外用及注射剂型
- 编程 - 通过SOTAX溶出度软件在单一验证平台定义方法与规格
- 测试 - 基于预设时间点、流速及介质变化运行溶出曲线，实现全程可追溯
- 记录 - 通过用户权限管理、审计追踪、无限方法编程及报告功能实现完整可追溯性
产品亮点
实时的释放结果
通过连接分光光度计即时分析溶出活性物质，是获取溶出结果的最快途径。The CP pump will fill the flow cells connected to each dissolution vessel and the multi cell changer of the spectrometer will move to the appropriate position，确保每个容器均可即时测定。本系统支持与不同品牌及型号的紫外-可见分光光度计组合使用。
从原料药到新型制剂
溶出度测试是剂型生产过程中监测参数的超指标。CE 7smart流池法溶出度测试系统拓展了实验设计范围，作为能对原料药、中间体和最终剂型进行可重复测试的药典级溶出度测试系统，它从预配方和表征到生产过程控制（IPC）和质量控制（QC）测试，均能提供关键信息。
Biorelevant methods
Envisioned to mimic in-vivo conditions more accurately than beaker methods, the Flow-Through Cell technique was born to ambitiously push dissolution testing borders. Compatible with biorelevant media from level zero to three, the CE 7smart remains a powerful and flexible tool to change pH on the fly in extended and delayed release dosage form testing. The CE 7smart is also a method of choice for poorly soluble compounds BCS class II and IV.
Volume flexibility
The CE 7smart user can adapt his open and closed system settings to its real solubility and sensitivity method requirements, simply adjusting the required media volume. From 50 to 5000 mL, maintaining the same hydrodynamic conditions in every volume condition, the CE 7smart allows a reproducible positioning of the dosage form into the cell.
Evaluating subcutaneous injectables
BioJect™ is an innovative cell designed to evaluate the drug release of subcutaneous injectables. It broadens the application of flow-through cell dissolution testing to include subcutaneous peptide formulations. BioJect™ utilizes a compendial dissolution framework to enhance its functionality. The cell, with a 22.6 mm ID, now incorporates a hydrogel-based reservoir (agarose), ensuring precise and consistent control over pore size and diffusion characteristics.
模块
WinSOTAX®plus
用于管理方法、结果和报告的溶出度管理软件。