TRS100 Quantitative Pharmaceutical Analysis System

BY
Agilent
Agilent
Description

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.

Key Differences

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
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

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.

A range of standard and custom trays for tablets, capsules, liquids, and powders is available.


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 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.

Technical Specification
Downloads
TRS100 Quantitative Pharmaceutical Analysis System
Related Products