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Identification and quantification techniques of polymorphic forms - A review.

Julian Ticona Chambi1, Cinira Fandaruff2, Silvia Lucia Cuffini1

  • 1Pós-Graduação em Engenharia e Ciência de Materiais, Instituto de Ciência e Tecnologia (ICT), Universidade Federal de São Paulo (UNIFESP), São Paulo, Brasil.

Journal of Pharmaceutical and Biomedical Analysis
|March 1, 2024
PubMed
Summary

This review highlights solid-state techniques for detecting and quantifying Active Pharmaceutical Ingredient (API) crystalline forms (polymorphs). It compares methods like PXRD and spectroscopy based on detection limits and pharmacopeia standards for pharmaceutical quality control.

Keywords:
IdentificationLODLOQPharmacopeiaPolymorphsQuantificationSolid-state techniques

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Area of Science:

  • Pharmaceutical Science
  • Solid-State Chemistry
  • Analytical Chemistry

Background:

  • Polymorphism in Active Pharmaceutical Ingredients (APIs) can significantly affect therapeutic efficacy.
  • Accurate qualitative and quantitative monitoring of pharmaceutical solid forms is crucial for quality control.
  • Detecting and quantifying crystalline forms, including polymorphs, at low levels is essential.

Purpose of the Study:

  • To review and emphasize the importance of selecting appropriate solid-state techniques for API polymorphism detection and quantification.
  • To evaluate techniques based on limits of detection (LOD) and quantification (LOQ), pharmacopeial specifications, and international guidelines.
  • To provide a comprehensive analysis of various solid-state techniques for pharmaceutical solid form analysis.

Main Methods:

  • Analysis of powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), Infrared and Raman spectroscopies, and solid-state nuclear magnetic resonance (NMR).
  • Review of major pharmacopeias (Argentine, Brazilian, British, European, International, Japanese, Mexican, USA).
  • Comparison of techniques regarding advantages, disadvantages, LOD, and LOQ values for APIs.

Main Results:

  • PXRD offers an advantage using calculated diffraction patterns from Crystallographic Information Frameworks (CIFs) as reference patterns.
  • The Rietveld method combined with PXRD allows for lower LOD values for minority phases without calibration curves.
  • Raman spectroscopy detects polymorphs in small particles; solid-state NMR excels in quantifying crystalline and crystalline-amorphous mixtures.

Conclusions:

  • The selection of appropriate solid-state techniques is vital for accurate and efficient control of API polymorphism.
  • Reference materials must be pre-identified with their corresponding polymorphs for accurate identification analyses.
  • This review serves as a guide for controlling API polymorphism in pharmaceutical compounds with efficiency and accuracy.