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Infrared (IR) Spectroscopy: Overview01:09

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Metallic solids such as crystals of copper, aluminum, and iron are formed by metal atoms. The structure of metallic crystals is often described as a uniform distribution of atomic nuclei within a “sea” of delocalized electrons. The atoms within such a metallic solid are held together by a unique force known as metallic bonding that gives rise to many useful and varied bulk properties.
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Mid-Infrared Spectroscopy of Pharmaceutical Solids.

Harry G Brittain1

  • 1Center for Pharmaceutical Physics, Milford, NJ, United States.

Profiles of Drug Substances, Excipients, and Related Methodology
|April 22, 2018
PubMed
Summary

Infrared spectroscopy is a powerful tool for analyzing pharmaceutical solids, revealing details about their solid-state properties, polymorphism, hydrates, and cocrystals. This review covers the technique

Keywords:
Acidic drug substancesAcids, bases, and saltsAttenuated total reflectanceBasic drug substancesCocrystal systemsFTIR samplingFourier transformInfrared spectroscopyMolecular vibrationPolymorphismQualitative identificationSolvatomorphismSpectroscopy of polyatomic molecules

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Area of Science:

  • Pharmaceutical Solid-State Characterization
  • Spectroscopic Techniques
  • Materials Science

Background:

  • Infrared absorption spectroscopy is a well-established method for the physical characterization of pharmaceutical solids.
  • Spectra analysis, particularly energy values, provides insights into solid-state properties.
  • The technique is valuable for identification, polymorphism studies, hydrate analysis, and cocrystal investigations.

Purpose of the Study:

  • To provide a comprehensive overview of the theoretical foundations of infrared spectroscopy.
  • To illustrate the practical applications of infrared spectroscopy in pharmaceutical solid-state analysis.
  • To highlight the growing importance of FTIR in studying drug substances, hydrates, and cocrystals.

Main Methods:

  • Review of theoretical principles underlying infrared absorption spectroscopy.
  • Analysis of spectral data to understand solid-state properties.
  • Examination of case studies involving drug substances, hydrates, and cocrystals.

Main Results:

  • Infrared spectroscopy offers a robust method for identifying pharmaceutical solids.
  • Trends in spectral energy values correlate with solid-state properties.
  • FTIR is effective for evaluating polymorphism, hydrate water content, and cocrystal systems.

Conclusions:

  • Infrared spectroscopy is a versatile and powerful technique for pharmaceutical solid-state characterization.
  • The methodology is essential for understanding polymorphism, hydrates, and cocrystals.
  • This review provides foundational knowledge and practical examples for applying infrared spectroscopy.