Pharmaceuticals
Elemental / phase analysis to molecular structure
X-ray diffraction (XRD) and X-ray fluorescence (XRF) are pivotal in drug discovery and quality control. Rigaku excels in single crystal diffraction instruments, crucial for both macromolecules and small molecules. Our range spans from crystal screening to 3D structure refinement, ensuring critical quality attributes for regulated and non-regulated environments.
Drug discovery
Rigaku provides comprehensive solutions for drug discovery, including protein crystallization kits, high-throughput structure elucidation tools, and innovative SAXS systems tailored for automated protein analysis. Their unique PDF methods for small molecules demonstrate their commitment to advancing drug discovery processes.
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Preformulation
Various stages of the discovery, design, development, and formulation processes heavily depend on analytical methods. These methods include diffraction for structural information, spectroscopy for molecular details, fluorescence for elemental data, and thermal techniques for phase determination.
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Formulation
Formulation development is intricate, with numerous paths and potential pitfalls. Rigaku assists by providing a wide range of analytical tools and expertise, aiding in achieving target product performance. Their solutions cover atomic purity, molecular identity, structure, microstructure, and phase behavior, benefiting formulation scientists.
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Manufacturing & QC
Rigaku offers diverse analytical technologies for consistent drug product quality. They employ fluorescence, spectroscopy, and diffraction alongside quantitative methods to monitor blend uniformity and solid form changes. X-ray CT microscopy assesses 3D microstructure, correlating with dissolution behavior and therapeutic efficacy for pharmaceutical equivalence.
Learn more >Data integrity support for Rigaku products
For pharmaceutical companies, GMP compliance is an essential element in balancing quality assurance and regulatory adherence. Rigaku provides systems compliant with international regulations such as FDA 21 CFR Part 11 and EU-GMP Annex 11, creating an environment where users can operate with confidence. Our proprietary SureDI library, developed from the “ER/ES System & Audit Trail” of our X-ray diffraction systems, goes beyond electronic records and electronic signatures to include comprehensive user management, audit trails, and data integrity. This functionality has also been extended to Rigaku’s thermal analysis instruments and energy-dispersive X-ray fluorescence spectrometers, enabling regulatory compliance across three analytical technologies. As a result, quality control departments can ensure compliance while the production floor benefits from efficient and reliable data management. Rigaku’s systems are a secure choice for managers and decision-makers, and a practical partner for operators in daily workflows.
Polymorphs
Polymorph screening is required for an active molecule in order to identify the distinct crystalline forms, hydrates/solvates, and cocrystals that can exist, as well as to determine their thermodynamic inter-relationships. Rigaku provides a range of customizable diffraction, spectroscopic and thermal analysis systems with performance to match abbreviated and comprehensive screens.
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