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The role of XRD in pharmaceutical research and manufacturing
Processes like recrystallization, grinding and compaction can alter the polymorphic form of active pharmaceutical ingredients (APIs) and excipients. Therefore, USP <941> and ICH Q6A mandate identifying and quantifying crystalline and amorphous forms using X-ray powder diffraction (XRPD).
XRPD reveals molecular structures in powders, helping track polymorphic transitions caused by temperature, humidity, and any other external stress. Accurate monitoring ensures the correct form is present in final drug products, preventing adverse effects or market withdrawal.
Malvern Panalytical’s XRD solutions for pharmaceuticals
XRPD is a critical analysis for regulatory compliance, and for ensuring the best outcomes for patients and your business. However, it can become a bottleneck in the drug development workflow. Consequently, many laboratories outsource their XRPD measurements, leading to long feedback loops that slow your speed to market.
Malvern Panalytical’s X-ray diffractometers are the perfect solution for pharmaceutical scientists, quality assurance teams, and lab managers looking for reliable, high-quality, easy-to-operate XRD instruments. With automated sample handling, intuitive touch screens, superior data quality and market-leading software, our XRD systems are accessible for users at any expertise level, reducing dependency on outsourcing and specialized training, and providing confidence around solid form.
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Aeris compact X-ray diffractometer
The world’s first compact XRD system, Aeris delivers the power and quality of floor-standing XRD system in a compact, user-friendly, plug-and-play design.
- Easy to use: Generate reproducible results with minimal XRD expertise
- High-quality data, fast: Get a complete pattern to fingerprint your API in just 5 minutes
- High sensitivity: Achieve low detection limits for product quality you can be confident in
- Space-saving design: Fits into any lab setup and requires only a standard household power socket
Aeris fits seamlessly into any lab, and with OmniTrust software, ensures compliance with 21 CFR Part 11 requirements in a simple manner. What’s more, its modular design and HighScore analysis software make Aeris a flexible, future-proof investment for all your solid-state analysis needs.
Empyrean XRD range
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Empyrean range
Multipurpose X-ray diffractometers for your analytical needs
Empyrean is the all-in-one XRD solution, supporting XRPD at ambient and non-ambient conditions (variable temperature and relative humidity), various X-ray scattering methods (Small-angle X-ray scattering – SAXS – for nanomaterials characterization and Pair-distribution analysis – PDF – particularly relevant for amorphous materials), and imaging applications (Computed Tomography – CT – for non-destructive testing of final drug products). Built for flexibility, it adapts seamlessly to both research and manufacturing environments.
For pharmaceuticals, Empyrean’s high resolution and exceptional sensitivity are invaluable for detailed structural studies.
Empyrean can even be designed to meet your specific needs. For custom sample holders, optical modules, or specialized techniques, consult with a Malvern Panalytical representative to create a tailored solution for your team.
Why choose Malvern Panalytical?
The result of a merger between Malvern Instruments and PANalytical, previously Philips Analytical, Malvern Panalytical benefits from over sixty years’ experience in the art and science of X-ray Diffraction. Our analytical instruments are used by pharmaceutical companies across the globe, from start-ups to big pharma, to support their processes from drug discovery to quality control, as well as in peer-reviewed research.
We leverage our expertise to provide more than just instruments to our customers. This includes our support services portfolio, including Smart Manager for the Empyrean platform. We also organize frequent webinars, providing users with the opportunity to keep up with the latest innovations and have their questions answered by industry experts.