CE 7smart离线收集模式
流池法溶出度测试系统，可自动采集样本。
- 收集 – 将溶出度测试样品收集于试管或小瓶
- 控制 – 受控水动力学
- 开环 – 开环配置，具备无限吸收条件，自动pH值调节
- 闭环 – 闭环配置，固定容积（15-4000毫升），适用于药典规定的低体积溶出度测试
- IVIVC – 基于开环配置，简化的体内外相关性分析
- 应用 – 原料药、口服、外用及注射剂型的可重复测试
- 清洁 – 自动化清洁程序
产品亮点
简单高效
离线采集溶出测试样品是实现溶出度测试自动化的最简便方式。通过分流阀从恒定流速中取样，样品由CP泵输送，在流向收集的试管/小瓶过程中，通过流通池头部的圆形滤膜进行过滤。样品存储于C613或C615自动进样器中。流程中确保样品始终采用统一处理方式，以实现最高效率。
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.
Testing subcutaneous injectables
BioJect™ is a specialized cell designed to assess the drug release of subcutaneous injectables. It extends the scope of flow-through cell dissolution testing to subcutaneous peptide formulations. Built on a compendial dissolution setup, BioJect™ expands its capabilities. The 22.6 mm ID cell now supports a hydrogel-based reservoir (agarose), offering precise and reproducible control over its pore size and diffusion behavior.
Options
WinSOTAX®plus
Dissolution software to manage methods, results, and reports.