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Near-Infrared for Pharmaceutical Analysis
FT-NIR – the worry-free way to monitor your process and assure product quality
Keep your pharmaceutical manufacturing process under control and your products within specifications with just a push of a button. Fourier transform near-Infrared spectroscopy (FT-NIR) has been widely used in the pharmaceutical industry as a rapid alternative to time-consuming, solvent intensive, wet-chemistry methods and chromatographic techniques (HPLC, GC). Rely on NIR to quickly verify incoming raw materials, monitor reaction progress and quantify final product formulation with ease.
Use FT-NIR spectroscopy for these applications:
- Raw material identification
- PAT for on-line or in-line process monitoring
- Tablet content uniformity and coating analysis
- 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.
| Problem | NIR 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. |
| Feature | Benefit |
|---|---|
| Analyze powders & liquids directly | Eliminate solvents and hazardous chemicals |
| Sampling through glass & packaging materials | Non-destructive and eliminates sample preparation |
| Higher resolution than dispersive or filter systems | Better specificity for many pharmaceutical APIs |
| Simple & reproducible analysis | Reduce operator variability |
| Faster analysis than many techniques | Get results quicker and achieve higher throughput |
| Amenable to remote sampling via fiber optics | More flexible sampling & on-line analysis |
Streamline your analysis with these FT-NIR products
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 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.
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