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Related Concept Videos

Raman Spectroscopy Instrumentation: Overview01:26

Raman Spectroscopy Instrumentation: Overview

440
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...
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Raman Spectroscopy: Overview01:20

Raman Spectroscopy: Overview

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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...
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Old Polymorph, New Technique: Assessing Ritonavir Crystallinity Using Low-Frequency Raman Spectroscopy.

Manolya K Hatipoglu1, Yeakub Zaker1, Daniel R Willett1

  • 1Division of Complex Drug Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, St. Louis, Missouri 63110, United States.

Analytical Chemistry
|October 5, 2023
PubMed
Summary
This summary is machine-generated.

Quantitative Raman spectroscopy methods were developed to detect ritonavir polymorphs in tablets. Low-frequency Raman (LFR) analysis offers a faster, sample-sparing alternative to X-ray powder diffraction (XRPD) for drug quality control.

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Materials Science

Background:

  • Ritonavir's lower solubility crystal form (form II) discovered post-market necessitated reformulation into an amorphous state.
  • Hot-melt extrusion is a key process for stabilizing amorphous ritonavir, preventing crystallization.

Purpose of the Study:

  • To develop and validate quantitative low- and mid-frequency Raman spectroscopy (LFR and MFR) methods.
  • To characterize ritonavir polymorphs (form I and form II) in commercial tablets.
  • To compare Raman spectroscopy with X-ray powder diffraction (XRPD) for polymorphism assessment.

Main Methods:

  • Quantitative LFR and MFR spectroscopy were developed and validated.
  • Commercial ritonavir tablets from multiple manufacturers were stored under accelerated conditions (40 °C, 75% RH).
  • Polymorph crystallization was assessed and compared against quantitative XRPD results.

Main Results:

  • Form I crystallization occurred in two products, and form II in another, after four weeks.
  • Raman spectroscopy demonstrated comparable limits of detection to XRPD for both polymorphs.
  • Transmission LFR allowed direct identification and detection of polymorphs in tablets with reduced measurement time (10 s vs. 66 min for XRPD).

Conclusions:

  • LFR is a viable, rapid, and sample-preparation-free technique for assessing ritonavir polymorphism in real-world pharmaceutical samples.
  • Raman spectroscopy offers similar analytical performance to XRPD but with significant time savings.
  • This method enhances drug quality control and manufacturing efficiency.