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Related Concept Videos

Raman Spectroscopy: Overview01:20

Raman Spectroscopy: Overview

480
The underlying principle of Raman spectroscopy is based on the interaction between light and matter, specifically molecules' inelastic scattering of photons. When a monochromatic beam of light, typically from a laser source, interacts with a sample, most scattered light has the same frequency as the incident light. This is known as Rayleigh scattering.
However, a small fraction of the scattered light exhibits a frequency shift due to the exchange of energy between the incident photons and...
480
Raman Spectroscopy Instrumentation: Overview01:26

Raman Spectroscopy Instrumentation: Overview

470
A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...
470

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Developing In Situ Chemometric Models with Raman Spectroscopy for Monitoring an API Disproportionation with a Complex

Shikhar Mohan1, Yi Li1, Kevin Chu2

  • 1Gilead Sciences, Foster City, CA 94404, USA.

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Summary
This summary is machine-generated.

A new in situ Raman method quantitates multiple solid forms, including metastable ones, aiding drug development. This technique enables real-time monitoring of polymorphic conversions for optimal active ingredient delivery.

Keywords:
Raman spectroscopyX-ray diffractionprocess analytical technologyprocess monitoringsalt disproportionation

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Area of Science:

  • Analytical Chemistry
  • Materials Science
  • Pharmaceutical Sciences

Background:

  • Characterizing complex polymorphic landscapes with multiple metastable forms presents significant analytical challenges.
  • Existing Raman calibration methods lack precedents for quantitating more than two polymorphs, especially with metastable variants.

Purpose of the Study:

  • To develop a novel in situ Raman spectroscopy method for characterizing the disproportionation of salts with complex polymorphic forms.
  • To establish a robust Raman calibration procedure for accurate in situ quantitation of multiple polymorphs, including metastable ones.

Main Methods:

  • Developed an in situ Raman method utilizing disproportionation experiments to generate calibration samples across various polymorph ratios.
  • Combined in-line Raman measurements with off-line X-ray diffraction for accurate solid form quantitation.
  • Incorporated solid concentration variation into the calibration dataset to enhance quantitation accuracy.

Main Results:

  • Successfully developed and validated an in situ Raman method capable of accurately quantitating each solid form in complex mixtures.
  • Demonstrated the method's efficacy even with multiple metastable and stable freebase forms.
  • Gained kinetic insights into thermodynamically driven polymorphic conversions.

Conclusions:

  • The developed spectroscopic and mathematical approach enables simultaneous quantitation of multiple polymorphs in real-time.
  • This method provides crucial kinetic understanding to guide salt selection for optimal active ingredient delivery in drug products.
  • Offers a valuable tool for advanced solid-state characterization and process monitoring in pharmaceutical development.