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NMR spectrometers consist of a strong magnet, a radiofrequency transmitter, and a detector attached to a computer console for recording spectra of samples containing NMR-active nuclei. In first-generation NMR instruments called continuous-wave spectrometers, the resonance frequencies of the nuclei are determined by frequency-sweep or field-sweep methods. The magnetic field strength is fixed and the rf signal is swept in the former, while the radiofrequency signal is fixed and the magnetic field...
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通过使用流采样器通过NIR频谱基线监测连续混合过程动态.

Dhavalkumar S Patel1, Rafael Méndez2, Rodolfo J Romañach1

  • 1Department of Chemistry, University of Puerto Rico at Mayaguez, Puerto Rico 00681, United States.

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概括

一个新的流量采样器在直接压缩制造过程中稳定了近红外光谱基线. 这允许准确的实时过程监测和控制连续粉末混合.

关键词:
化学测量 化学测量 化学测量连续制造 连续制造制造接近红外光谱基线的近红外光谱基线.PAT知识经理是PAT知识经理.过程分析技术 过程分析技术过程动态 过程动态稳定状态稳定状态

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科学领域:

  • 制药制造业 制药制造业 制药制造业
  • 过程分析技术 (PAT) 是一种分析技术.
  • 频谱学是一种光谱学.

背景情况:

  • 在直接压缩连续制造中的不受控制的粉末流量会导致光谱基线变化.
  • 现有的方法依靠光谱预处理来消除基线漂移,可能会掩盖过程动态.
  • 有效的实时过程监控需要稳定的光谱数据.

研究的目的:

  • 为了控制光谱基线变化,使用用于直接压缩连续制造的流采样器.
  • 通过实时基线监测在连续混合过程中评估过程动态.
  • 建立一种方法来区分质量稳定状态和质量流变化的方法.

主要方法:

  • 使用以每分钟8转和35公斤/小时的吞吐量运行的流样本仪,以确保均的粉末流动.
  • 采用移动块标准偏差 (MBSD) 方法来监测实时基线变化,集成到 synTQ 程序中.
  • 在质量稳定状态下使用校准混合物 (40-60% w/w 乙氨基) 确定了MBSD值.
  • 研究了带有和没有光谱转换的部分最小平方 (PLS) 回归模型.
  • 应用变形图分析来评估整体工艺变异.

主要成果:

  • 流采样器在质量稳定状态下实现了可重现和稳定的光谱基线,归因于受限的粉末流.
  • 门MBSD成功地将质量稳定状态与连续混合期间的质量流变化区分开来.
  • 没有光谱转换的PLS模型显示,独立混合物的预测偏差和RMSEP较低.
  • 变形图分析提供了对采样和分析错误的见解.

结论:

  • 流采样器有效地控制了直接压缩连续制造中的光谱基线变化.
  • 实时MBSD监控提供了一种可靠的流程控制方法,可以区分稳定状态和动态状态.
  • 没有光谱转换的优化PLS模型提高了混合统一性的预测准确性.