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TRS100 Quantitative Pharmaceutical Analysis System

TRS100 Quantitative Pharmaceutical Analysis System

The TRS100 enables fast, easy-to-use whole tablet or capsule content uniformity and polymorph screening for pharmaceutical finished-product testing and formulation development. Easier to implement than other spectroscopic methods, Agilent’s transmission Raman spectroscopy (TRS) technology allows simple method development and deployment for quantitative analysis in quality control applications.

A TRS100 system can reduce content uniformity, assay, and ID tests to minutes per batch, saving significant cost and speeding up your quality control workflow. Sample preparation and consumables are not needed, meaning skilled analytical resources are not required. Content uniformity testing methods using transmission Raman have been approved by regulators using ICH and regulatory authority-acceptable protocols.

TRS100 Quantitative Pharmaceutical Analysis System

TRS100 Quantitative Pharmaceutical Analysis System

Product Details

Features
  • Assay hundreds of tablets or capsules in minutes.
  • Works with intact capsules and coated tablets of most thicknesses.
  • Requires no sample preparation, wet chemistry, or skilled testing resources.
  • Quantifies APIs and excipients in a single measurement.
  • Achieves a limit of quantification as low as 0.1% w/w.
  • Quantifies polymorphs in intact tablets.
  • Lean calibration models—easy to build and maintain.
  • Methods approved by regulators.
  • A range of sample trays and accessories for tablets, capsules, liquids, and powders are available.
  • Built-in technical controls ensure the security of your data, control access, and facilitate compliance as defined by US FDA 21 CFR Part 11 and EU Annex 11 regulations.
  • Choose sustainability: The Cary 60 UV-Vis received My Green Lab’s ACT (Accountability, Consistency, Transparency) label after independent audit for its environmental impact throughout the product lifecycle.
Specifications
Calibration Standards
  • NIST SRM706a polystyrene
  • NIST SRM2246 green glass
  • Calibration tray with mercury argon light source
Compliance
  • 21 CFR Part 11
  • USP <858>
  • USP<1858>
  • EP <2.2.48>
Laser Power
  • 650 mW
Laser Wavelength(s)
  • 830 nm
Resolution
  • < 8 cm-1 (FWHM)
Sample Tray Types (Optional)
  • Tablets
  • Capsules
  • Powders
  • Vials
  • Well plates
Spectral Range
  • 50 to 2,300 cm-1
How It Works

Transmission Raman

The TRS100 is a non-destructive, bulk analytical technique used in pharmaceutical R&D and QC manufacturing—for both qualitative and quantitative testing, such as content uniformity analysis. The fast scan time and automated tray system allows hundreds of samples to be analyzed in a single session. A range of standard and custom trays for tablets, capsules, liquids, and powders is available.

The TRS100 software is compliant to 21 CFR part 11, and relevant USP and EP chapters.

Non-destructive bulk analysis

The TRS100 obtains a measurement by directing the laser through the sample from the underside. The resulting Raman spectrum comes from the bulk of the sample and is therefore representative of the entire sample.

The TRS100 uses an 830 nm laser, specifically chosen for pharmaceutical samples as a balance between signal levels, and competing fluorescence of common pharmaceutical excipients.

Calculate your content uniformity ROI

Use our value calculator to see for yourself how much and how soon you could save compared to your current workflows.

The typical example, where 3 batches are analyzed per day, delivers ~$450K of savings in less than 3 years. TRS100 benefits from no sample preparation, no solvents, lower cost of analysis, and lower cost of ownership. Higher volume products and more laborious workflows pay back even faster!

Environmental impact

The TRS100 has been independently audited for its environmental impact and has received the ACT (Accountability, Consistency, Transparency) label, published by My Green Lab.  See how you can reduce your lab’s environmental impact with sustainability-driven innovation.

Applications

Content uniformity testing

The TRS100 is used for assay and content uniformity (CU) analysis. This fast, non-destructive technique, requiring no sample preparation, can generate a quantitative CU result in less than 15 minutes.

The TRS100 has been approved by regulators and is used to create cost-effective analytical workflows. Watch our customer webinars and learn how pharmaceutical companies are streamlining their QC analytical workflows.

Polymorphs

The TRS100 can be used for polymorph and crystallinity analysis of powders and whole intact tablets for both qualitative and quantitative analysis. The TRS100 can detect residual crystallinity with a limit of detection (LOD) of 0.1-1% w/w.

The ability to ‘see’ inside your pharmaceutical product non-destructively and measure the same sample repeatedly has useful applications in formulation development and stability studies.

Sample versatility

The TRS100 can be used to analyze a variety of sample types including—tablets, hard and soft gel capsules, powders, vials, cuvettes, and well plates.

The versatility of sample presentation options enables a breadth of potential applications, which can all benefit from bulk high-throughput screening.

Technology

Transmission Raman Spectroscopy (TRS)

Transmission Raman Spectroscopy (TRS) is an ideal method for quantitative analysis of mixtures such as tablets capsules, powders, liquids and suspensions.

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