Portable Raman spectrometer QTRam
The spectrometer is equipped with control software that meets the requirements of 21 CFR Part 11 regulation for quantitative analysis of the composition and uniformity of pharmaceutical raw materials and products. QTRam is simply portable and does not require control via an external notebook, making it an ideal tool for at-line analysis and transfer between different productions or halls. The spectrometer is equipped with its own touch screen for operating the control software. This implemented software enables the creation of quantitative and qualitative methods for data analysis and evaluation of measured samples with output to a secure database of reports. The instrument can be equipped with pharmaceutical libraries of Raman spectra and ASTM calibration standards.
Main applications of the QTRam spectrometer:
- Uniformity of composition - control and ensuring the correct content of active substance (API) in tablets, capsules and gels
- Mixing uniformity - control and ensuring correct mixing of the tablet: transmission Raman enables fast acquisition of spectra from wide sample areas, adapters for selecting the "spot size" measuring area according to the application (2 mm, 4 mm, 6 mm, 8 mm, etc.) are also available
- Formula development - support of QbD concept for quantification of API and excipients in the final dose
- Counterfeit detection - fast composition check = quality/quantity, calculation of API content