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The TRS100™ enables fast, easy to use content uniformity & polymorph analysis for regulated pharmaceutical testing

Quantitative Analysis of Tablets, Capsules and Powders

Streamlined Quality Control Testing

  • Assay hundreds of tablets or capsules in minutes
  • Works with intact capsules, coated tablets and 10mm thickness
  • No sample preparation, wet chemistry or skilled resource
  • Quantify APIs and excipients in a single measurement
  • LOQ as low as 0.1% w/w - Even for polymorphs in intact tablets
  • Lean calibration models - Easy to build and maintain
  • Methods approved by regulators

Transmission Raman for Quality Control

The TRS100 enables high-throughput, non-destructive, non-invasive bulk assay of all common dosage forms without sample preparation. Easier to implement than other spectroscopic methods, Cobalt’s transmission Raman (TRS™) technology allows simple method-development and deployment in QC applications.

Replacing HPLC

Using a single TRS100 an operator can replace 8-10 HPLC units and their operators. The TRS100 has a flexible sample tray system that can work with coated tablets, intact capsules, glass vials and powders to measure hundreds of samples per hour. Sample preparation and consumable items are not required. CU testing methods using Transmission Raman are approved by regulators. Switching to TRS from HPLC allows significant cost savings per batch and streamlined method development.

Other Applications

The TRS100 can be used for other applications, including quantitative measurement of polymorphic content in intact tablets <1% w/w – significantly better than XRPD. For formulation development work, the ease and flexibility of model building makes TRS a practical alternative to wet methods.

Content Uniformity Testing

Replacing HPLC Methods – Reducing Resource​

  • Whole tablet/capsule analysis – no sub-sampling
  • Works with intact samples up to 10mm thick
  • No sample preparation, wet chemistry or skilled testing resource
  • LOQ 0.1-1% w/w
  • Methods approved by regulators

Transmission Raman Spectroscopy

Transmission Raman spectroscopy (TRS) is ideal for high throughput content uniformity analysis. A TRS measurement takes only a few seconds per sample with good accuracy, precision and linearity of response. TRS technology is specific and sensitive for nearly all APIs, excipients and lubricants but is largely insensitive to interference from water/moisture, particle density or surface coatings.

CU Testing

The TRS100 needs no consumables or solvents and no preparatory chemical skills. A single TRS100 CU batch report can be completed in <30 minutes from start to finish, which allows a high throughput for the QC function and low resource usage compared to traditional HPLC methods.

Compared with NIR, transmission Raman methods are easier to develop as scattering effects, such as those due to differences in tablet compaction, have a much smaller impact on the prediction result. TRS is quicker, has a higher sensitivity (lower % LOD/LOQ), can penetrate through thick samples and has easy-to-understand distinct spectral features from each formulation component.

Regulatory Compliance

TRS100 methods are compatible with regulatory requirements as an alternative to HPLC for content uniformity testing – see this webinar. The instrument and software are designed to meet relevant USP, EP and 21 CFR part 11 requirements.

Polymorph Quantification

Measuring Polymorph Concentration in Dosage Forms

Detecting Low Concentrations Easily

Most active pharmaceutical ingredients (APIs) are crystalline materials with a well-defined polymorphic form. Manufacturing or processing can change that form, and, increasingly, amorphous APIs are used by formulators to increase bioavailability. The TRS100 can directly measure low-energy crystalline vibrational modes (the phonon mode region) to quantify polymorph content in seconds and to a high precision in intact, formulated samples.

The most common technique for quantitative polymorph analysis is XRPD, which has a sensitivity limit of around 5% w/w and requires tablets to be crushed and sampled. The TRS100 can detect residual polymorphs in a fully formulated amorphous API tablet with a limit of detection (LOD) of 0.1-1% w/w. The LOD is comparable with ssNMR but requires no sample preparation, is much quicker and requires less resource.

Dimensions: 1124 mm wide / 521 mm high / 575 mm deep

Safety Class 1 laser system – interlocked, CE marked
Power requirements 90-264VAC 50-60Hz
Software (Content QC)

21 CFR Part 11 compliant
Runs on Windows platform
Eigenvector Solo prediction engine

Hardware Dedicated transmission Raman platform built to GAMP 5 guidelines
Sample Trays

300cm2 active sample area, <5cm sample height above the tray
Standard capsules and tablet sizes
Custom fit tray
Beam Enhancer™ Technology available

TRS100 Product Note

Brochures

Development of an Alternative to HPLC for Individual Tablet Assay by Transmission Raman

Application Notes

Return on Investment for Content Uniformity Analysis by Transmission Raman Spectroscopy

Application Notes

Photon Diode Signal Enhancer

Technical Notes

Transmission Raman Spectroscopy (TRS)

Technical Notes

Co-Crystal Analysis by TRS

Application Notes

View all related knowledge library articles

TRS100 Instrument Demos

Upcoming TRS100 demos are taking place in:

If you are interested in a TRS100 instrument demo, get in touch!

Quantitative analysis of intact tablets, capsules and powders

Quantitative analysis of intact tablets, capsules and powders