Pharmaceutical Applications of Klarite®

Klarite substrates provide a 10⁶ enhancement of normally weak Raman signals, opening up the use of Raman techniques across a broader range of analyses in the pharmaceutical industry. Raman spectroscopy is already a proven methodology in drug development and production. However, until now, the inherently weak signals associated with this technique have limited its use to bulk materials. Klarite substrates provide a route by which the use of Raman spectroscopy can be extended to lower concentrations and smaller sample quantities. Substrates are available mounted on numbered and bar-coded microscope slides for ease of identification and traceability.

Ultra Rapid Cleaning Verification

The development of Klarite substrates for use in Surface Enhanced Raman Spectroscopy (SERS) delivers exciting new concepts capable of providing long awaited improvements in cleaning verification.

• Ultra rapid sample response times prevent a measurement backlog, common amongst HPLC users, minimising production downtime.
• Production downtime is reduced from days to hours, allowing companies to significantly increase production volumes.
• In contrast to HPLC, all components in an analyte mixture will be
  detected and displayed simultaneously – no need to ‘search’ for contaminants.
• Spectra allow the identification of molecular functional groups, allowing end users to apply targeted cleaning procedures.
• Ease of use allows routine SERS detection technology to be used by non-experts.
• Flexible technology opens up a wide range of instrumentation for all customers, large or small.

Partners are actively being sought by Renishaw Diagnostics to exploit the Pharmaceutical applications potential of Klarite.

Cleaning Verification Application Note

Benefits of Klarite Substrates for Pharmaceutical Applications

Klarite offers significant advantages to the production and testing of various drug materials and drug candidates:

• Low levels of detection and investigation of active components
• Detection of impurities and contaminates in drug manufacture
• Structural information including chirality
• Investigation of drug interactions

In addition, the Klarite surface enhanced Raman diagnostic technique is also clearly differentiated from other advanced chemical fingerprinting techniques such as mass spectrometry, conventional Raman and IR spectrometry:

• Ability to extend the limits of detection beyond any other non-destructive technique
• Completely compatible with water-based samples
• Mature analytical instrumentation