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文章基本信息

  • 标题:Internal Structure Quality Control of Solid Pharmaceuticals. A Comparative Study
  • 作者:Silvia Imre ; Timea Haidu ; Oana Ponta
  • 期刊名称:Acta Medica Marisiensis
  • 电子版ISSN:2247-6113
  • 出版年度:2016
  • 卷号:62
  • 期号:1
  • 页码:95-100
  • DOI:10.1515/amma-2015-0104
  • 语种:English
  • 出版社:Walter de Gruyter GmbH
  • 摘要:Objective: The aim of the study was a comparative investigation by spectral and thermal analysis in order to asses a number of characteristics of different varieties ofrawmaterials of ursodeoxycholic acid and ibuprofen. The different dissolution behavior of two ursodeoxycholic acid pharmaceutical product by crystallinity pattern was investigated. Methods: Raw materials of ursodeoxycholic acid and ibuprofen were used. IR spectroscopy, differential scanning calorimetry and X-Ray Diffraction Analysis were applied. Results: The results show no crystallinitydifferences for different batches of the tested drugs. No solid solid transition was proved during sample preparation for transmission IR analysis. Conclusions: A combination of two more affordabletests by IR spectrometry and differential scanning calorimetry lead to the same results as X-Ray diffraction analysis for crystallinity similarity assessment of the studied substances. The dissolution differences of test drugs were not related to the polymorphism of the raw materials.
  • 关键词:IR spectroscopy ; DSC ; X-Ray Diffraction Analysis (XRD) ; ibuprofen ; ursodeoxycholic acid
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