TRS100 – Transmission Raman – Content Uniformity & Polymorph Quantification

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TRS100 – Transmission Raman – Content Uniformity & Polymorph Quantification

TRS100 – Transmission Raman – Content Uniformity & Polymorph Quantification

TRS 100 Rapid Analysis System – Transmission Raman

The TRS100 enables Content uniformity analysis, Rapid formulation development and Pharmaceutical R&D.

Check out this powerful Return on Investment (ROI).

Click to view Cobalt TRS100 brochure.

Click to view Cobalt TRS100 Application Note.

Click to view Cobalt TRS100 Technical Note.

Click to view the Press Release.

TRS100

Rapid Analysis System – Transmission Raman

The TRS100 enables content uniformity analysis, Rapid formulation development and pharmaceutical R&D.

Quantitative analysis of tablets, capsules and powders

  • Assay hundreds of tablets or capsules in minutes
  • Lean calibration models – Easy-to-build and maintain
  • Works with intact capsules, coated tablets and 10mm thickness
  • No sample preparation, wet chemistry or skilled testing resource
  • Quantify APIs, excipients, polymorphs and other crystalline forms in a single measurement
  • LOQ as low as 0.1% w/w – even for polymorphs in intact tablets
  • 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 (TRSTM) technology allows simple method-development and deployment in QC applications.

Replacing HPLC Methods – Reducing Resource

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.

  • 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

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.

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.

Cobalt’s transmission Raman technology enables high-performance non-destructive and non-invasive bulk assay of dosage forms such as capsules, tablets, gels, solutions/suspensions or powders without sample preparation. Easier to implement than other spectroscopic methods, Cobalt’s transmission Raman technology simplifies method-development for routine quality control. See below for more information on Transmission Raman and the benefits of this technology (including tech & app note).
The instrument is able to analyse a large number (typically >100) of capsules or coated tablets. Once a model is built the user simply fills the removable tray and loads it into the instrument. The analysis is automated and the in-built multivariate analysis and reporting tools convert your batch samples into CU test results. The software is 21CFR part 11 compliant.
Our technology is specific and sensitive for nearly all APIs, excipients and lubricants but is largely insensitive to interference from water/moisture, content density or surface coatings.

Transmission Raman Spectroscopy

Transmission Raman Spectroscopy is a method for analysing diffusely scattering materials such as powders, tablets, suspensions and other chemical mixtures. It is ideally suited to rapid quantitative analysis of pharmaceutical dosage forms and mixtures, which is the main purpose of Cobalt’s TRS100 instrument. The benefits include:

  • Bulk quantification of intact formulations – the whole of the tablet is measured without sub-sampling
  • Suppresses interfering surface fluorescence and Raman signals from capsules and coatings
  • Penetrates >10mm into powders and tablets
  • Rapid analysis times (seconds or less per sample)
  • Accuracy to ca. 1% relative error
  • No sample preparation

Check out this powerful Return on Investment (ROI).

Click to view Cobalt TRS100 brochure.

Click to view Cobalt TRS100 application note.

Click to view Cobalt TRS100 technical note.

Click to view the press release.

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