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Drug Development
Pre-clinical development, toxicology, pharmacology, formulation, process development
Shimadzu offers many solutions to accelerate the drug development process and expedite market launching. Flexible and user-friendly systems are available to meet a wide range of users’ needs.
Ultra-Fast Impurity Characterization LCMS-IT-TOF System
Formulation-related impurities need to be characterized. The combination of Ultra-fast LC, Prominence UFLC and an LCMS-IT-TOF mass spectrometer provides an analysis platform which is able to acquire higher resolution data more quickly. MSn analysis and accurate MS information provide more reliable results.
Ultra-Fast Method Development LC System
LC method development is a time consuming process. One means of improving method performance is the application of fast chromatography. Ultra-Fast analysis using Prominence UFLC accelerates and simplifies the method development process. The hardware does not need to be changed for both conventional LC and UFLC modes.
Ultra-Fast LC System for Dissolution Testing
Dosage forms are getting more complicated and multi-component drugs are becoming more prevalent. Prominence UFLC systems with CLASS Agent/Agent Report sorfware shorten sample run times and improve LC analysis dissolution testing efficiency. In addition to reducing analysis times, development lab solvents consumption is also reduced.
LC-AccuSpot MALDI Polymer Analysis System
Development/manufacturing QA/QC of pharmaceutical excipients and polymers for DDS are important and protocols are becoming more complicated. MALDI ionization of a mixture causes ion suppression and makes detection of all components extremely difficult. An LC-AccuSpot MALDI system enables automated spotting of LC peaks for MALDI analysis. It is suitable for terminal functional group analysis, monomer unit analysis, molecular characterization of polymers like co-polymer, polylactate.
Characterization of Polymorphs for Formulation Study
The evaluation and study of crystal polymorphs for formulation are important in the drug development stage. Shimadzu 50 series and 60 series thermal analysis systems are widely used in material development, production and control processes. TA-60WS software is compatible with general-purpose software and supports regulatory compliance with the CLASS-Agent data management system. IRPrestige-21, a higher sensitivity IR spectrophotometer, further assists in characterization.
Nano and Single nano Particle Size/Distribution Analysis
　Particle size measurements provide important distribution behavior information. SALD-7101, which uses a UV semiconductor laser, can observe aggregation, dispersion and dissolution in the range between 10nm and 300µm. IG-1000 is a recently launched single-nano particle size analyzer. It is based on Induced Grating Method (IG method) and enables single nano particle size measurement. This IG method is a unique technology from Shimadzu, and incorporates dielectrophoresis and diffraction.
