Cobalt -Model TRS100 -Pharmaceutical Quality Control System
The TRS100 enables fast, easy to use whole tablet or capsule assay & polymorph analysis for pharmaceutical QC testing. Easier to implement than other spectroscopic methods, Agilent`s transmission Raman spectroscopy (TRS) technology allows simple method-development and deployment in QC applications. A TRS100 system can reduce content uniformity (CU), assay, and ID tests to minutes per batch, saving significant cost and speeding up your QC workflow.
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- 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 resources needed
- Quantifies APIs and excipients in a single measurement
- 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
Content Uniformity Testing
- 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 (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. Spectral features are sharp, distinct and easy-to-interpret and assign to each formulation component.
Polymorph Quantification
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.