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    Quantitative Analysis Of Mannitol Polymorphs - X-Ray Powder Diffractometry. Exploring Preferred Orientation Effects.

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    Publication date
    2009-08-12T12:57:52Z
    Author
    Grimsey, Ian M.
    Booth, S.W.
    Campbell Roberts, Sarra N.
    Williams, Adrian C.
    Keyword
    Mannitol
    Polymorphism
    Quantitation X-ray powder diffractometry
    Particle size
    Sample rotation
    Peer-Reviewed
    Yes
    
    Metadata
    Show full item record
    Abstract
    Mannitol is a polymorphic pharmaceutical excipient, which commonly exists in three forms: alpha, beta and delta. Each polymorph has a needle-like morphology, which can give preferred orientation effects when analysed by X-ray powder diffractometry (XRPD) thus providing difficulties for quantitative XRPD assessments. The occurrence of preferred orientation may be demonstrated by sample rotation and the consequent effects on X-ray data can be minimised by reducing the particle size. Using two particle size ranges (<125 and 125¿500 ¿m), binary mixtures of beta and delta mannitol were prepared and the delta component was quantified. Samples were assayed in either a static or rotating sampling accessory. Rotation and reducing the particle size range to <125 ¿m halved the limits of detection and quantitation to 1 and 3.6%, respectively. Numerous potential sources of assay errors were investigated; sample packing and mixing errors contributed the greatest source of variation. However, the rotation of samples for both particle size ranges reduced the majority of assay errors examined. This study shows that coupling sample rotation with a particle size reduction minimises preferred orientation effects on assay accuracy, allowing discrimination of two very similar polymorphs at around the 1% level.
    URI
    http://hdl.handle.net/10454/3288
    Version
    No full-text available in the repository
    Citation
    Grimsey, I.M., Booth, S.W., Campbell-Roberts, S.N. and Williams, A.C. (2002). Quantitative Analysis Of Mannitol Polymorphs - X-Ray Powder Diffractometry. Exploring Preferred Orientation Effects. Journal of Pharmaceutical and Biomedical Analysis. Vol. 28, No. 6 pp. 1149-1159.
    Link to publisher’s version
    http://dx.doi.org/10.1016/S0731-7085(02)00053-5
    Type
    Article
    Collections
    Life Sciences Publications

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