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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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[Polymorphs of clopidogrel bisulfate].

Yi Liu1, Hai-Wei Huang, Jian-Min Wu

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Yao Xue Xue Bao = Acta Pharmaceutica Sinica
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Polymorphism in clopidogrel bisulfate raw materials was investigated. Fourier transform infrared spectroscopy (FTIR) and powder X-ray diffraction (p-XRD) revealed distinct crystalline forms, aiding quality control.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Clopidogrel bisulfate is a widely used antiplatelet medication.
  • Understanding the polymorphism of its raw materials is crucial for consistent drug quality and efficacy.

Purpose of the Study:

  • To investigate and characterize the polymorphism of clopidogrel bisulfate raw materials from various sources.
  • To establish a basis for the quality evaluation of clopidogrel bisulfate.

Main Methods:

  • Fourier transform infrared spectroscopy (FTIR) for chemical structure analysis.
  • Powder X-ray diffraction (p-XRD) for crystalline structure identification.
  • Differential scanning calorimetry (DSC) for thermal property analysis.

Main Results:

  • Samples were broadly classified into two main polymorphic groups based on FTIR and p-XRD.
  • One patent material exhibited a distinct polymorphic form.
  • DSC provided further detailed characterization of the identified polymorphs.

Conclusions:

  • The study successfully identified and differentiated key polymorphic forms of clopidogrel bisulfate raw materials.
  • The findings provide a foundation for robust quality control and assurance of clopidogrel bisulfate.
  • Characterization of polymorphism is essential for pharmaceutical product consistency.