With the help of Raman spectroscopy, it is possible to measure without contact through transparent packages, so that the sample package remains intact and you are also not exposed to unnecessary risk during the analysis, e.g. when measuring potentially hazardous substances. In addition, the excitation wavelength of 1064 nm used minimizes the fluorescence of the sample, which would otherwise make measurements impossible: you can effectively identify many more substances, including colored or fluorescent samples. The spectrometer software includes, among other things, a commercial library of pharmaceuticals. Creating your own spectral databases that allow the identification of unknown substances is a matter of course. Validable methods that can be transferred from one device to another are used to verify the expected material. Communication of the device with an external PC is possible in the form of Ethernet or WiFi. Multi-component analysis of mixtures (mixture analysis) and transfer of results to the laboratory information system (LIMS) is of course also possible.
NanoRam-1064 fully complies with all applicable regulations, including 21 CFR part 11 and part 1040.10, and plays an integral role when cGMPis required. It meets the requirements for Raman spectroscopy, including the US Pharmacopeia < 858 > , European Pharmacopeia 2.2.48, Japanese Pharmacopoeia 2.26 and Chinese Pharmacopeia.
Raman spectroscopy is a suitable technology for compliance with PIC/S&GMP guidelines (100% assurance of starting material identity). In addition to the device itself, we offer a wide range of services, including support for method development and new libraries and IQ/OQ/PQ implementation services.