Application of FP Method using Theoretical Calculation of Scattered X-Rays for Pharmaceuticals Impurities Elemental Analysis

DOI

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Other Title
  • 医薬品不純物元素分析への理論散乱X線を用いたFP法の適用検討

Abstract

<p>The United States Pharmacopeia (USP) has established guidelines for general analysis using X-ray Fluorescence (XRF) methodology. Energy Dispersive X-ray Fluorescence (EDX) can be utilized in the screening process for the control of elemental impurities in pharmaceutical products. The Fundamental Parameter (FP) method using theoretical calculation can reduce the number of standard samples for quantitation. This study proposes the use of the Scattered X-ray Corrected-FP method, thus Background FP method, which uses scattered X-rays for quantitation of impurity for 12 elements, cadmium, lead, arsenic, mercury, vanadium, cobalt, nickel, iridium, platinum, ruthenium, rhodium and palladium in cellulose, talc, mixture of cellulose, talc and titanium oxide, and tosilate matrices to verify the some important performance qualifications of USP <735> through the comparison with calibration curve method.</p>

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Details 詳細情報について

  • CRID
    1390578625301475584
  • DOI
    10.57415/xshinpo.48.0_249
  • ISSN
    27583651
    09117806
  • Text Lang
    ja
  • Data Source
    • JaLC
  • Abstract License Flag
    Allowed

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