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PANalytical


XRPD and XRF analytical solutions

PANalytical provides the best-in-class performance for a wide range of drug production tools and support. These range from rapid material identification and confirmation of raw materials, to intermediate and final drug analyses and reporting.

X-ray fluorescence spectrometry (XRF) is a non-destructive technique with high sensitivity and simple or no sample preparation. This technique can be used in pharmaceutical production and quality control to detect and quantify elemental impurities down to sub-ppm levels. XRF can also be applied to the high-precision quantification of catalyst residues present in active ingredients or final drug products. Flexibility and ease of use are among the many advantages of XRF as well as the ability to analyze sample quantities ranging from 50 mg to 5 g. Not only this, rapid scan based identification of all materials, including excipients, APIs and raw materials, is made possible through XRF FingerPrinting.

X-ray powder diffraction (XRPD) can detect and measure polymorphic contamination, detect crystallographic changes, and quantify active ingredients in the final dosage form. As a result it can be used to monitor and improve production efficiency and cost, as well as to control the quality of the finished product.

Examples where PANalytical solutions have proved beneficial to drug manufacturing and quality assurance and quality control programs are listed below.

X-ray Fluorescence

Epsilon 3XLE (energy dispersive XRF)
Typical uses include:
• Elemental and trace heavy metal screening
• Rapid identification of raw materials when combined with FingerPrint

Zetium (wavelength and energy dispersive XRF)
Typical uses include:
• Inorganic excipient elemental analysis (C to U) for major, minor and trace concentrations from sub ppm to % range
• Enhanced trace element quantification of mineral excipients (e.g. Carbonates) when combined with Pro-Trace

X-ray Diffraction

CubiX³ Pharma
Typical uses include:
• API crystal morphology monitorinig
• API quantification and final dose forms(s)
• Dedicated XRPD PAT programs

X’Pert³ Powder
Typical uses include:
• API crystal morphology monitoring
• API quantification and final dose forms(s)
• % crystallinity quantification

Empyrean
Typical uses include:
• API crystal morphology monitoring
• API quantification and final dose forms(s)
• % crystallinity quantification
• Tablet pressure control (inner micro-structure visualization) by CT

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