Raman System for Content Uniformity - QTRam®

The QTRam® is a portable Transmission Raman Spectrometer driven by B&W Tek’s award-winning, patent-pending STRaman® technology. This technology facilitates quick, non-destructive quantitative analysis, suitable for content uniformity testing of end products such as capsules and tablets.

Transmission Raman is an exceptional technique for quick, non-destructive testing of content uniformity, and vital tests for solid dosage forms. The portable QTRam® can be used for at-line quantitation of tablet composition, which minimizes the time taken and the related production delays that result from having to submit samples to the laboratory for in-process and end product testing.

Calibrations for multi-competent testing can be developed from a single Raman spectrum. The benefit of the QTRam® measurement of the unscathed samples is that solid-state properties of the sample, including crystallinity and polymorphic form, can be measured along with the chemical composition.

The QTRam® can be effortlessly operated using 21CFR Part 11 compliant software for quantitative analysis, on the integral tablet computer. The portable form factor permits users to use it in the lab or for at-line analysis.

Applications

Content uniformity — The API’s dosage uniformity can be ensured in solid dosage end product, such as capsules, tablets, and gelsCounterfeit detection — API quantity can be calculated to guarantee the exact drug with the correct dosageFormulation development — QbD initiatives to measure API and excipient concentrations in finished dosage forms can be supported