In situ 3D topographic and shape analysis by synchrotron radiation X-ray microtomography for crystal form identification in polymorphic mixtures
Yin, XZ; Xiao, TQ; Nangia, A; Yang, S; Lu, XL; Li, HY; Shao, Q; He, Y; York, P; Zhang, JW; Zhang, JW (reprint author), Chinese Acad Sci, Shanghai Inst Mat Med, Ctr Drug Delivery Syst, Shanghai 201210, Peoples R China.
2016
发表期刊SCIENTIFIC REPORTS
ISSN2045-2322
卷号6期号:-页码:
文章类型期刊文献
摘要Polymorphism denotes the existence of more than one crystal structure of a substance, and great practical and theoretical interest for the chemical and pharmaceutical industries. In many cases, it is challenging to produce a pure crystal form and establish a sensitive detection method for the identification of crystal form in a mixture of polymorphs. In this study, an accurate and sensitive method based on synchrotron radiation X-ray computed microtomography (SR-mu CT) was devised to identify the polymorphs of clopidogrel bisulphate (CLP). After 3D reconstruction, crystal particles were extracted and dozens of structural parameters were calculated. Whilst, the particle shapes of the two crystal forms were all irregular, the surface of CLP II was found to be rougher than CLP I. In order to classify the crystal form based on the quantitative morphological property of particles, Volume Bias Percentage based on Surface Smoothing (VBP) was defined and a new method based on VBP was successfully developed, with a total matching rate of 99.91% for 4544 particles and a lowest detectable limit of 1%. More important for the mixtures in solid pharmaceutical formulations, the interference of excipients can be avoided, a feature cannot achieved by other available analytical methods.
关键词Clopidogrel Bisulfate Controlled-release Quantification Spectroscopy Diffraction Microscopy Impurity Kinetics Tablets
DOI10.1038/srep24763
收录类别SCI
语种英语
WOS记录号WOS:000374501000002
引用统计
文献类型期刊论文
条目标识符http://ir.sinap.ac.cn/handle/331007/25751
专题中科院上海应用物理研究所2011-2018年
通讯作者Zhang, JW (reprint author), Chinese Acad Sci, Shanghai Inst Mat Med, Ctr Drug Delivery Syst, Shanghai 201210, Peoples R China.
推荐引用方式
GB/T 7714
Yin, XZ,Xiao, TQ,Nangia, A,et al. In situ 3D topographic and shape analysis by synchrotron radiation X-ray microtomography for crystal form identification in polymorphic mixtures[J]. SCIENTIFIC REPORTS,2016,6(-):—.
APA Yin, XZ.,Xiao, TQ.,Nangia, A.,Yang, S.,Lu, XL.,...&Zhang, JW .(2016).In situ 3D topographic and shape analysis by synchrotron radiation X-ray microtomography for crystal form identification in polymorphic mixtures.SCIENTIFIC REPORTS,6(-),—.
MLA Yin, XZ,et al."In situ 3D topographic and shape analysis by synchrotron radiation X-ray microtomography for crystal form identification in polymorphic mixtures".SCIENTIFIC REPORTS 6.-(2016):—.
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