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Characterization of pharmaceutical compounds and the analysis of complex modern formulations, together with an increasing need for data to support regulatory submissions, means that the pharmaceutical industry now depends on a range of analysis technologies.
Both X-ray powder diffraction (XRPD) and X-ray fluorescence (XRF) spectroscopy are recognized as valuable techniques in many areas of drug discovery, development and manufacture.
X-ray powder diffraction
By non-destructively determining the crystallographic constitution of samples, XRPD is used to:
- determine crystal structures
- screen for polymorphs or hydrates
- detect changes in morphology or crystalline state of active ingredients (e.g. during processing or at non-ambient conditions)
- detect and quantify crystalline impurities (in some cases down to 0.05%)
- determine the crystallinity or the crystallite size of a compound
- analyze and optimize final dosage forms
XRPD data on a compound or drug is also required for new product registration and patent application/protection.
X-ray fluorescence
XRF spectroscopy is a non-destructive technique, which requires simple or even no sample preparation.
It detects and quantifies major and minor elements in fillers, lubricants, coatings and other excipients 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.
PANalytical solutions
PANalytical has a range of systems for X-ray analysis within the pharmaceutical industry. All are designed to meet regulatory requirements, including suitability for use in a 21 CFR Part 11 compliant laboratory environment.
X'Pert PRO MPD: X-ray powder diffractometer that offers the ideal platform for demanding analysis. PreFIX, a unique approach with pre-aligned interchangeable optics and stages, makes the system flexible and future proof. The groundbreaking X'Celerator detector provides ultra-fast data collection with superior resolution.
Axios: high-end wavelength-dispersive XRF (WDXRF) spectrometer with sophisticated counting electronics, the fastest and most accurate goniometer, unmatched sensitivity and a powerful software package.
Epsilon 5: high-end energy-dispersive XRF (EDXRF) spectrometer, incorporating patented technologies, that out-performs its rivals in sub-ppm determinations such as the analysis of catalyst residues.
MiniPal 4: benchtop EDXRF instrument with a new silicon drift detector that delivers the highest resolution in its sector. Ideal for quantifying the major elements in fillers, lubricants, coatings and other excipients.
