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PANalytical, Epsilon 1 Pharma.

PANalytical

PANalytical offers a wide range of key analytical techniques and products that are used in the pharmaceutical industry for research, development and quality control purposes. These rapid non-destructive analytical techniques such as near-infrared spectroscopy (NIR), X-ray diffraction (XRD) and X-ray fluorescence spectrometry (XRF) can be used for a large variety of (bio-)pharmaceutical applications including drug discovery, pre-formulation, formulation, stability testing and final product quality control.

PANalytical products and solutions provide the pharmaceutical industry with analysis methods for elaborate material characterization and also help the industry to meet strict regulatory requirements.

Meeting the needs in drug development and quality control

panalyticalSpeed, reproducibility, ease of use and the adherence to the demands of a highly regulated environment are key requirements for routine pharmaceutical applications. Many X-ray analytical tools have earned their place in today’s pharmaceutical development laboratories, especially in the areas of pre-formulation and formulation of solids. The non-destructive nature of the analyses often allows a multitude of process steps to be performed on the same sample without destroying its original structure.

Standardization and regulation have been embraced by the pharmaceutical community. Instruments used in this environment must provide secure operation, data validation and data traceability.

PANalytical offers a comprehensive portfolio of X-ray diffraction (XRPD) and X-ray fluorescence (XRF) instruments and related modules that are invaluable in areas of interest such as full characterization of active pharmaceutical ingredients (API), both small molecule and biologics, and excipients.

Non-destructive material characterization and analysis solutions

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.

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 compliant solutions for both X-ray powder diffraction (XRPD) and X-ray fluorescence spectrometry (XRF)
  • PANalytical provides a suite of tools such as 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

PANalytical’s headquarters are in Almelo, the Netherlands. Fully equipped application laboratories are established in Japan, China, the US, Brazil, and the Netherlands. PANalytical is active in all but a few countries of the world. This worldwide sales and service network ensures unrivalled levels of customer support.

With a broad product portfolio and an extensive collection of patents and proprietary technologies, PANalytical continuously creates and sustains a distinct competitive advantage.

PANalytical is part of Spectris plc, the productivity-enhancing instrumentation and controls company.

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Contact

PANalytical B.V.
Lelyweg 1
7602 EA ALMELO
The Netherlands
Tel.: +31 546 534444
Fax.: +31 546 534598
info@panalytical.com

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X-ray powder diffraction in drug development

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Epsilon 1 Pharma

Pharmaceutical catalyst residue analysis at the push of a button

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A fully integrated floorstanding energy dispersive X-ray fluorescence (EDXRF) spectrometer, the Epsilon 5 combines advanced elemental excitation capabilities with sophisticated instrument control and analytical software. Epsilon 5 provides high-performance trace elemental impurity analysis ideal for USP and ICH Q3D applications.

Installation Qualification (IQ) and Operational Qualification (OQ) are available and the Enhanced data security software can be configured to support 21 CFR Part 11 compliance.

X’Pert³ Powder

A cost-effective, multipurpose X-ray diffraction platform.

The X'Pert³ Powder system offers a solution for high-throughput, high-quality phase identification and quantification, small-angle X-ray scattering, pair distribution function analysis and non-ambient diffraction. The system complies with the latest and most stringent X-ray and motion safety norms and with its eco-friendliness and reliability the X'Pert³ Powder is ready for the future.Installation Qualification (IQ) and…

Zetium

X-ray fluorescence spectrometry (XRF) enables elemental analysis of a broad range of materials, including liquids, solids, and loose powders. Developed to satisfy the most challenging process control and R&D applications, the Zetium spectrometer leads the market in high-quality design and novel features for sub ppm to percentage analysis of elements across the periodic table including all elements required for elemental impurity analysis.

Zetium is a revolutionary spectrometer based on numerous years of expertise and success with the company's extensive analytical X-ray portfolio. The platform showcases SumXcore technology, which combines EDXRF and WDXRF for the best of both worlds.
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