HDI-Near-Infrared-Pharmaceutical-Analysis-230x195

NIRS:实验室传统湿化学方法的实用替代方案

近红外光谱(NIRS)是耗时、高溶剂消耗的湿化学法和液相色谱法的实用替代方案,已被广泛用于制药行业。NIRS 可用于物料接收环节或生产现场的快速测试,便于在生产线旁而非实验室中进行常规分析。

利用 NIRS 实时监测生物制药或固体制剂生产过程,帮助控制产品质量和连续流程工艺。

咨询NIRS

 

Use FT-NIR spectroscopy for these applications:

较传统技术而言,NIRS 有下列优势:

  • 无样品制备 - 可穿透玻璃和其他包装材料采样
  • 无损测量
  • 准确、可靠分析
  • 降低成本
  • 增加样品通量
  • 远程采样(使用廉价光纤)

见“NIRS 常见问答” ›

  • Lyophilized material quality verification
  • Hot-melt extrusion blend consistency
  • Fermentation and cell culture monitoring

NIR plays an important role in implementing quality by design (QbD) principles that ensures your product is compliant and meets performance specifications. With the move to continuous manufacturing NIR is an ideal process analytical technology (PAT) that minimizes risk and reduces costs to your organization. As a QA/QC solution, use NIR spectroscopy to quickly verify active pharmaceutical ingredients (API) and excipients as well as for final tablet release testing.


ProblemNIR Solution
Analyze powders & liquids directlyMy tablets do not appear uniformly coated and my API content variability is larger than expected. How can I verify my tablet and API uniformity without extensive, time-consuming testing?Use the Antaris II NIR Spectrometer with tablet autosampler to perform simultaneous reflection and transmission spectroscopy to assess tablet coating consistency (reflection) and quantify API content uniformity (transmission). This non-destructive technique allows further analysis of the tablets to find the root cause of tablet inconsistency.
During storage my lyophilized materials is changing color. How can I quickly find out what’s wrong?Use the Antaris II NIR Spectrometer with integrating sphere to measure the material directly through the glass container. This approach lets you determine moisture, potency, identity, purity and stability without opening the sealed containers. Stability testing through packaging materials becomes quick and easy.
My batch manufacturing is showing variability in the intermediate product. How can you minimize this variability?Use the Antaris MX NIR Analyzer as a continuous in-line check at multiple points in your process to perform analytics in real time. This allows you to quickly adjust process parameters to maximize product yield and consistency, reducing the risk of batch rejection.
My hot-melt extrusion (HME) drug formulation API is consistently within my acceptance limits. How can I ensure API uniformity before I end up with a bad batch?Use the Antaris MX NIR Analyzer with fiber optic probe connected to the exit die of the extruder to continuously measure API and other ingredient levels. This approach ensures product consistency and prevents waste of your high-value materials.
FeatureBenefit
Analyze powders & liquids directlyEliminate solvents and hazardous chemicals
Sampling through glass & packaging materialsNon-destructive and eliminates sample preparation
Higher resolution than dispersive or filter systemsBetter specificity for many pharmaceutical APIs 
Simple & reproducible analysisReduce operator variability
Faster analysis than many techniquesGet results quicker and achieve higher throughput
Amenable to remote sampling via fiber opticsMore flexible sampling & on-line analysis

Streamline your analysis with these FT-NIR products

Antaris II FT-NIR Analyzer

Antaris II FT-NIR Analyzer

The Thermo Scientific Antaris II FT-NIR Analyzer sets an industry standard for process and quality control analytics. This NIR spectrometer is designed for use in laboratories, on factory floors, in pilot plants or at productions lines, providing laboratory-level -based FT-NIR performance in a ready-for-plant package. No matter what the sample, the Antaris II NIR Analyzer provides robust, reliable data collection and for at-line, on-line and in-line analysis. Customize an Antaris II for specific applications or choose the Antaris II MDS Method Development Sampling System, which includes transmission, fiber-optic and integrating sphere diffuse reflection analysis all in one turnkey system.

The Antaris II analyzer provides:

  • High performance combined with rugged design
  • Reproducible regardless of configuration, maintenance, user or environment
  • System-to-systems repeatability for method transfer
  • Easy software set up usingvia dedicated validation and application programs
  • A regulatory compliance and validation-ready instrument
  • Complete worldwide support programs
  • High reliability for low cost of ownership

Antaris IMX FT-NIR Analyzer

Antaris MX FT-NIR Process Analyzer

The Thermo Scientific Antaris MX FT-NIR Process Analyzer offers remote analysis using fiber-optic multiplexing technology with integrated communications for real-time feedback on your production output. The Antaris MX Analyzer is a complete, fit-for-purpose solution for point-of-use materials analysis and online or inline process monitoring. It is the only near-infrared analyzer featuring truly simultaneous measurements of up to four collection points along your production line. This NIR spectrometer is also self-referencing at every measurement point, assuring continuous background collection and signal-to-noise reproducibility. This means less downtime for your manufacturing line because you do not have to remove the probes for system qualification checks.  

The Antaris MX NIR Analyzer helps you:

  • Obtain faster process feedback
  • Maintain line uptime
  • Improve product quality
  • Lower operating costs
  • Increase product yields
  • Increase process efficiency
Complete System Qualification
✓ Comprehensive vendor package
✓  Factory traceability
✓ Certified service technicians
21 CFR Part 11 Tools
✓ E-record management
✓ E-signature management
✓ Data Security and audit trails
System Validation
✓ End-to-end validation
✓ Complete documentation
Operator Training
✓ Technique & application
✓ Understanding of SOPs
✓ Complete training records

Featured Webinar

Ensuring Integrity of Drug Formulation from Development to QC

Listen to a panel of experts discuss when to use Raman, FTIR and NIR spectroscopy along the drug development pipeline to assure drug performance. 

Watch webinar

Ensuring Integrity of Drug Formulation from Development to QC

制药应用的主打 NIR分析仪

利用这些 NIR 产品使过程分析变得简洁高效

Thermo Scientific™ Antaris™ II FT-NIR 分析仪引领了行业标准,为工业现场提供了实验室级别的高性能FT-NIR 产品。无论何种样品,Antaris II NIR 分析仪均能在旁线、在线和原位分析中实现稳定、可靠的光谱数据采集。您可以根据具体应用定制相应模块的 Antaris II 或选择 Antaris II MDS 方法开发采样系统,MDS方法开发采样系统将透射、光纤和积分球漫反射分析完美整合至一套系统中。

Antaris II 分析仪:

  • 设计坚固,性能卓越
  • 无论何种配置、维护、用户或环境,均可重现
  • 系统间重复性,适用于方法转移
  • 通过专用的配套软件,轻松完成建模及验证工作
  • 满足监管及验证要求的合规仪器
  • 完整的全球支持方案
  • 低购置成本。

Thermo Scientific™ Antaris™ MX FT-NIR 过程分析仪利用光纤、实时多通道等技术,能够提供更优的 QC测试和远程过程监测,且可以通过工业标准通讯实现实时反馈控制。Antaris MX 是一款完整、实用的解决方案,适于快速材料分析和在线过程监测。Antaris MX 是唯一一款能够真正实现同步测量多通道(多至4个通道同时分析)的近红外分析仪。分析仪还能在每次样品光谱采集时同步采集背景光谱,稳定性无与伦比,背景采集或定量分析无需从工艺流程中取出探头。

Thermo Scientific™ Antaris™ Target 混合过程分析仪是与制药行业领导者合作开发而成,提供产品研发至生产之间的连续性和可放大性,便于实施控制策略。Antaris Target 是监测固体物料混合过程的最完整、可靠的分析解决方案,包括按照监管严格的医疗器械行业的质量体系要求所建立的可溯源设计模型。