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Timegated® Technology for pharmaceutical industry

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Quality control in pharmaceuticals with Timegated® Raman

Especially in the pharmaceutical research and development field the quality of the end product are regulated by stringent regulations by the authorities. To ensure its proper effect on the patient health, a product has to be manufactured with exacting quality. The FDA has published the Guide to Process Analytical Technology (PAT) in 2004, which defines a risk-based scientific approach, and aims at supporting innovation and efficiency in pharmaceutical development, manufacturing, and quality.

In light of these, it is of paramount importance to monitor the quality of the medicines and spectroscopy has played a major role. The great advantage of Raman spectroscopy over other techniques is that it only requires minimal to no sample preparation. Hence, Raman spectroscopy can be employed as a versatile tool for process analytical technology (PAT) for raw material identification, in-situ monitoring of reactions in developing active pharmaceutical ingredients (APIs), and for real-time process monitoring. Further for anti-counterfeiting applications, a spectral library of various pills can be developed and used for verification.

Our time-gated technology enables both contact and non-contact measurements and it is robust, insensitive to water, suitable for automation as well as a flexible measurement technique. Timegated® Raman resolves the current limitations in the production of pharmaceuticals by providing time-resolved detection of Raman signals by fluorescence suppression, and the possibility to simultaneously determine the fluorescence lifetimes. Visit our technology page for more information of the fluorescence suppression with Timegated® Raman.

All of this is done to enable more effective pharmaceutical manufacturing.

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Benefits of Timegated® Raman Technology in pharmaceuticals

 

Polymorphism and solid state variation present opportunities as well as great challenges in the pharmaceutical industry. Investigation of the properties of different forms of a commercial drug can lead to new products with improved onset time, greater bioavailability, sustained release properties, or other therapeutic enhancements. However, this investigation needs efficient tools. 

Timegated® Raman can provide several advantages for the studies of polymorphic forms of pharmaceutical substances and drugs, it

  • Gives information about
    polymorphic structures andchemical composition of pharmaceutical substances
  • Provides ease of use with efficient rejection of fluorescence interference
  • Does not require any sample pretreatment
  • Can be easily adapted to various different measurement and
    monitoring needs, e.g. to drug development, API synthesis, formulation and manufacturing, dissolution and bioavailability studies and to validate the drug stability in storage

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Timegated® Raman products for pharmaceuticals

Time-resolved Raman spectrometer

Until now many Raman analyses have been confined by the high fluorescence of pharmaceutical samples. The PicoRaman spectrometer uses patented time-gated technology which brings the benefits of Raman spectroscopy to a new level by rejecting the fluorescence. This enables a completely new window for research and medicine quality control in the pharmaceutical industry.

Raman spectroscopy is a viable tool for a plethora of applications in the pharmaceutical sciences. Raman is a recognized means to analyze non-destructively solid and liquid formulations, phase transitions and polymorphs in all phases of drug discovery, development and large-scale production.

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Time-resolved analysis with SampleCube

SampleCube enables easy, safe and representative measurements with Timegated® Raman. The SampleCube offers a sampling from a larger sample surface, limiting laser exposure of the sample, easy laser focusing and enhanced eye safety for pharmaceutical industry.

SampleCube has been designed and produced for pharmaceutical usage, and therefore it's main use case are powder samples but it can also be used to measure other flat or flattenable samples as well as liquid samples.

More Timegated® Raman products: products and services.

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