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The TRS100™ enables fast, easy to use whole tablet or capsule assay & polymorph analysis for pharmaceutical QC testing

Quantitative Analysis of Tablets, Capsules and Powders

Streamlined Quality Control Testing

  • Assay hundreds of tablets or capsules in minutes
  • Works with intact capsules and coated tablets of most thicknesses
  • No sample preparation, wet chemistry or skilled testing resource
  • Quantify APIs and excipients in a single measurement
  • Limit-of-Quantification as low as 0.1% w/w
  • Quantify 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 assay of 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.

Alternative to Wet Chemistry

Having TRS take some of the heavy lifting from HPLC allows significant cost savings per batch and faster release of products. A TRS100 can reduce CU, assay and ID tests to minutes per batch, compared with preparative techniques such as HPLC. The TRS100 has a flexible sample tray system that can hold hundreds of coated tablets or intact capsules or tens of glass vials or powder samples. Sample preparation and consumable items are not needed, meaning skilled analytical resource is not required. CU testing methods using Transmission Raman have been approved by regulators using ICH and regulatory-authority acceptable protocols.

Solid State Analysis

The TRS100 can be used for applications including quantitative measurement of polymorph content in intact tablets with LOQ of 0.1-1% w/w – significantly better than XRPD. TRS can be used for residual crystallinity in amorphous API/tablet analysis.

Content Uniformity Testing

Reducing Running Costs for QC Laboratories

  • Whole tablet/capsule analysis – no sub-sampling
  • Works with thick intact samples
  • 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 with low sensitivity to 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 minutes, 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 and can penetrate through thick samples. Spectral features are sharp, distinct and easy-to-interpret and assign to each formulation component.

Regulatory Compliance

TRS100 methods are compatible with regulatory requirements as an alternative content uniformity test – 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

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

Regulatory

21 CFR Part 11 compliant
Meets relevant USP and EP guidance

Laser Class 1 laser
830nm
Power

90-264VAC 50-60Hz

Software Requires Windows 7 or 10 Pro OS
Supplied with Cobalt's ContentQC™ analysis and management software
Integrated Eigenvector Solo chemometrics engine
Sample Trays

Standard trays for common capsule and tablet sizes
Customisable tray designs accommodate any sample
Optional Beam Enhancer™ technology available for increased speed and sensitivity

TRS100 Product Brochure

Brochures

Quantification of Crystallinity using Transmission Raman Spectroscopy

Application Notes

Quantification of Tablets Containing Multiple APIs Using Transmission Raman

Application Notes

Examples of Transmission Raman Applications at GSK

Seminar Videos

Quantitative Analysis of Pharmaceutical Bilayer Tablets using Transmission Raman Spectroscopy

Seminar Videos

Transmission Raman Spectroscopy for CU and Polymorphic Content Determination

Seminar Videos

Obtaining regulatory approval for QC batch release by transmission Raman: Bulk assay, uniformity and identification

Seminar Videos

Beam Enhancer Technology for High-Speed Transmission Raman Spectroscopy

Application Notes

Content Uniformity by Transmission Raman – Gaining Regulatory Approval

Webinars

Replacing HPLC: Transmission Raman for Content Uniformity

Webinars

View all related knowledge library articles

TRS100 News

Find out more about the TRS100:

Quantitative analysis of intact tablets, capsules and powders

Quantitative analysis of intact tablets, capsules and powders