SONY DSC

In collaboration with Federal Service for Surveillance in Healthcare, EnSpectr Inc. carried out research into application of 
Raman spectroscopy to determination of component concentration in injectable drugs.

The bottleneck of most of commercially available Raman spectrometers is water ID. Water is a poor Raman scatterer, even its signature is hard to reveal! R532 EsMix Raman spectrometer utilizes green laser which is optimal for efficient  excitation of a substance scattering. This and the EnSpectr optical bench know-hows make the R532+ analyzer  an outstanding device with an extraordinary  sensitivity.

Anti-counterfeiting of medical drugs is a new application of the R532+ Raman spectrometer. In accordance with the pharmaceutical industry regulations, ampouled liquid drugs for intravenous and intramuscular injections cannot be used in case of the concentration deviation of main active agents exceeding 10%. Considering the concentration of the main active agent to be usually about 1% or even less, it becomes an impossible task for any express method including Raman spectroscopy.

Indeed, nowadays mass analysis of ampouled liquid drugs involves breaking of the glass ampoule and long-term chromatographic analysis. But…

Welcome R532 EsMix,  the first express analyzer of water soluble injectable drugs.

ampoule medical anti-counterfeit

Perform fast & non-destructive authentication of water soluble injectable drugs in minutes

This requires measurement of Raman spectra of the kind given below, namely, Raman spectra of two common injectable drugs – Furosemide and No-Spa. The broad and intensive band on the right reproducible in both spectra is that of water. The sets of weak narrow bands on the left  correspond to the active agents of each pharmaceutical.

спектры препаратов на сайт

The EnSpectr high sensitivity devices and unique proprietary software enable precise analysis of injectant composition without opening or breaking the ampoule.

Unique EnSpectr EsMix sofware for authentication of water soluble drugs 

Issue: the intensities of the water band and those of the major component may differ by several orders of magnitude

The R532 EsMix sensitivity grade is sufficient to obtain an extremely stable and reproducible signature from an active agent with a concentration of several percent.

Issue: Background, noise, luminescence from the solution or ampoule, chemical shifting due to concentration deviation, etc.

The EsMix program allows minimizing the statistic measurement error of peak intensities and Raman shifts in a solution spectra occurring on repeated registration as a result of varying thicknesses of different parts of the ampoule, instrumental error, etc.

 

 

 

The sensitivity and reproducibility of the EnSpectr R532 EsMix units are close to those achieved by chromatographic analysis requiring package opening, preparation of samples by qualified personnel and being essentially time and cost consuming.

Therefore, it is now possible to realize Raman techniques using a set of R532 EsMix devices, one of which used for preparing calibration solutions and creating mathematical and other models for spectral analysis of ampouled drugs. The small size of EnSpectr portable devices and kitting enables to set up mobile laboratories for analysis pharmaceuticals in healthcare centers and pharmacies in most remote regions.

Learn more in R532 EsMix application note.