Pharmaceutical and biopharmaceutical development and manufacturing is becoming more complex and expensive. The need for more elaborate material characterization and tighter quality control requirements combined with tighter time constraints places considerable demands on analysis. Rapid non-destructive analytical techniques such as near-infrared spectroscopy (NIR), X-ray diffraction (XRD) and X-ray fluorescence spectrometry (XRF) have a wide range of (bio-)pharmaceutical applications including drug discovery, pre-formulation, formulation, stability testing and final product quality control. The main advantage these techniques provide is a reduction in analysis time providing higher throughput which can lower costs and shorten the time to market.
Non-destructive material characterization
Rapid non-destructive characterization is possible for all material types, including fine chemicals, active pharmaceutical ingredients (API) (small molecules and biologics), excipients (organic and inorganic) and final drug products.
Advanced material characterization is made possible with the easy incorporation of in situ non-ambient analysis, slurry flow cell analysis, and high-throughput with small quantity capabilities.
Pharmacopeial X-ray techniques
Internationally recognized pharmacopeial methods (both XRD and XRF) combined with technological developments such as ultra-fast, high-resolution detectors allow X-ray techniques to be at the forefront of (bio-) pharmaceutical development reducing analysis time while providing in-depth analysis of the sample.
PANalytical's comprehensive expertise gives you an advantage:
- X-ray analysis methods are comprehensive and proven, with 21 CFR Part 11 Audit Trail support for both X-ray powder diffraction (XRPD) and X-ray fluorescence spectrometry (XRF)
- In-house Expertise for Installation Qualification (IQ), Operational Qualification (OQ) and validation assistance (Design Qualification (DQ) / Performance Qualification (PQ))
- PANalytical Support - global 24-7 network assistance anytime, anywhere