Authentication & Anti-Counterfeiting of Medical Preparations

SONY DSC
In collaboration with the Federal Service for Surveillance in Healthcare, EnSpectr Inc. carried out research into application of Raman spectroscopy to determination of concentrations of active agents in ampouled preparations.
The bottleneck of most commercially available Raman spectrometers is water ID. Water is a poor Raman scatterer, even its signature is hard to reveal. The R532 Pharma spectrometer & analyzer utilizes a green laser which is optimal for efficient  excitation of substance scattering. This and the EnSpectr optical bench know-hows make R532  Pharma an outstanding device with an extraordinary  sensitivity.

Anticounterfeiting of water soluble medical preparations is a new application of the R532+-based model. In acccordance with the pharmaceutical industry regulations, ampouled liquid preparations for intravenous and intramuscular injections cannot be used with deviations of concentrations of main active agents exceeding 10%. Considering the fact that the concentration of the main active agent is usually about 1% or even less, it becomes a challenging task for any express method including Raman spectroscopy.

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

Welcome R532  Pharma,  the first express analyser of water soluble injectable drugs.

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Perform fast & non-destructive authentification of medical water preparations in minutes.

As an illustration, fast & non-destructive authentification of medical water preparations requires measurement of Raman spectra of two common injectable preparations – Furosemide and No-Spa. The broad and intensive band on the right reproducable 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 quantitative analysis of injectant composition without opening or breaking the ampoule.

Unique R532 Pharma sofware for authentification of water soluble drugs 

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

The R532 Pharma sensitivity grade is sufficient to obtain an extremely stable and reproducible signature from an active agent with a concetration of of the order of 1%.

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

The R532  Pharma program allows minimizing the statistic measurement error of peak intensities and Raman shifts in 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 R532 Pharma 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.

The small size of EnSpectr portable devices and kitting enables to set up mobile laboratories for analysis of medicinal preparations in healthcare centers and pharmacies in most remote regions.

 



 

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