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.

  • Solutions
  • System Lineup

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 Method Development LC System

Ultra-Fast LC System for Dissolution Testing

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 sorftware shorten sample run times and improve LC analysis dissolution testing efficiency. In addition to reducing analysis times, consumption of lab solvents is also reduced.





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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, the co-polymer, polylactate.

LC-AccuSpot MALDI Polymer Analysis System


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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. IRTracer-100, a higher sensitivity IR spectrophotometer, further assists in characterization.

Characterization of Polymorphs for Formulation Study


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Nano and Single nano Particle Size/Distribution Analysis

Particle size measurements provide important distribution behavior information. SALD-7500nano, which uses a UV semiconductor laser, can observe aggregation, dispersion and dissolution in the range between 7nm and 800µm.

Nano and Single nano Particle Size/Distribution Analysis


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Data Systems Data Systems and Data Management Tools
In the pharmaceutical industry, compliance to regulations and guidelines, such as CSV and PIC/S GMP and U.S. FDA 21 CFR Part 11, and the proper, efficient management of instrumentation and analytical data is required. Shimadzu's LabSolutions network-compatible analysis data system provides a fast and efficient management of instruments. Review our lineup of Data Management Software tools: LabSolutions LC/GC, LabSolutions DB, LabSolutions CS, LabSolutions GPC, LabSolutions IR, LabSolutions RF, Class-Agent and C-R8A Integrator.
Multi-vender software support Multi-vendor software support
Shimadzu has worked closely with other chromatography vendors to provide software drivers enabling other vendor's software to control our instrumentation. Review our lineup of vendor software drivers: LC driver for Waters Empower 3, GC driver for Waters Empower 3, i-Series LC driver for Waters Empower 3, LC drivers for Agilent's OpenLAB CDS EZChrom, GC driver for Agilent's OpenLAB CDS EZChrom, LC driver for Thermo Scientific Chromeleon 6.8, SPD-M30A Photodiode-array LC detector driver for Thermo Scientific Chromeleon 7.2.
LC-MS LCMS and LC/MS/MS
With the fastest multiple reaction monitoring (MRM) transition times available today, high-speed multi-analyte detection with 500 MRM transitions in one second, and unsurpassed polarity switching speed, the LCMS-8060, LCMS-8050, LCMS-8040 and LCMS-8030 triple quadrupole LC/MS/MS systems delivers speed beyond compare. Combining these advanced mass spectrometry technologies with Shimadzu's world-leading Nexera UHPLC performance creates a unique system approach to ultra fast mass spectrometry detection.
Dried Plasma Spots Dried Plasma Spots
NoviplexTM cards are a simple, powerful tool used to collect a volumetric sample of plasma (2.5 µL) from a non-volumetric application of whole blood in just minutes.
LC/HPLC Liquid Chromatography
For over 40 years Shimadzu has been recognized as a leader in innovative and robust Liquid Chromatography instrumentation. Liquid chromatography has become an integral analytical tool for researchers and analysts across the entire workflow of Pharmaceutical and Biopharmaceutical analysis from Drug Discovery through Clinical Trials and into production and Quality Assurance. Whether your requirements are for a stand-a-lone HPLC/UHPLC or as a front-end to Mass Spectrometry Shimadzu's line of liquid chromatography products will meet or extend your application needs. Review our comprehensive lineup of instruments: Nexera X2 UHPLC, Nexera SR UHPLC, Nexera MP Front End UHPLC, Nexera UC SFE-SFC, Nexera-e 2D-LC, Nexera-i Integrated UHPLC, Nexera HPLC/UHPLC Method Scouting, Prominence HPLC, Prominence UFLC, Prominence-I Integrated HPLC, Prominence nano LC, Prep LC, Crude2Pure Auto Purification/Powderization HPLC system, Co-Sense 2D-LC system for Bioanalysis.
Automated Protein Seperation Automated Protein Seperation
Perfinity technology, through automation and patented immobilized enzyme reactor columns, accelerates protein sample preparation workflows and provides reproducibility to proteolysis which cannot be obtained through traditional methods.
Prep-scale liquid chromatography Prep-scale liquid chromatography
Shimadzu has installed more than 2000 preparative HPLC systems throughout the world, and remains committed to improving the purity and speed of separation and making this technique more cost effective. Using our broad experience and technologies at various scales and in diverse fields, we have significantly enhanced the performance that can be obtained from preparative HPLC.
Crude2Pure Crude2Pure
Crude2Pure systems provide purification/powderization after retention and concentration of fractions of target compounds obtained by a preparative LC system.
Gas Chromatography Gas Chromatography
Since our first GC was introduced in 1956, Shimadzu has been developing innovative Gas Chromatography solutions. The Shimadzu GC product line encompasses the widest range of GC models, allowing the user to find an instrument matching the application requirements. Combining engineering expertise with the ability to listen to customer needs has resulted in an extensive array of GCs, sample handling, and data processing solutions.
Gas Chromatography Mass Spetrometry Gas Chromatography Mass Spectrometry
For over 30 years Shimadzu has been a leader in design innovations, such as our front access ion source, high efficiency ion optics, 20,000 µ/second scan speed, and post-quadrupole focusing lenses. Shimadzu is a market leader in system ruggedness combined with exceptional performance, simplified operation, and maintenance. Review our comprehensive lineup of instruments: the GCMS-TQ8040 with Smart MRM, GCMS-QP2010 Ultra, and the GCMS-QP2010 SE.
Nexera UC Nexera UC SFE-SFC
Supercritical fluid enables highly efficient sample extraction and chromatographic analysis. The Nexera UC uniquely combines supercritical fluid extraction and supercritical fluid chromatography to provide the industries’ first online Unified Chromatography system. Various configurations are available including on-line SFE-SFC-MS, SFC-MS, SFC Chiral Screening System, and SFC-UV.
LC-MS Nexera Comprehensive 2D-LC
Nexera-e enables the separation of even the most complex mixtures, providing a new level of knowledge and understanding of sample analytes. This is especially beneficial for the identification and quantitation of analytes in pharmaceutical impurities, peptides, lipids, and proteolytic digests.
LC-MS Nano-scale Liquid Chromatography
The Prominence nano is a nanoflow LC system consisting of Prominence Series units, including a flow line switching valve for nano-level flow control, and a solvent delivery unit that demonstrates excellent flow rate accuracy even at nano-level flows. Two system configurations are available, including a basic 1-dimensional system that adopts the trap injection system and a 2-dimensional system in which reversed-phase separation is automatically conducted following the first stage cation-exchange separation.
Micro-volume UV-Visible Spectrophotometers Micro-volume UV-Visible Spectrophotometers
The Shimadzu BioSpec-nano is a low-maintenance micro-volume spectrophotometer designed for the modern life science laboratory. It offers superior detection limits compared to comparable competitive systems, making it the perfect instrument for quantitation of DNA, RNA, protein analysis, and photometric measurements. Quantitation can be rapidly and simply measured required volumes of only 1µL. And, with dedicated functions, such as automated sample mounting and wiping, the BioSpec-nano offers a rapid 3-second analysis time and a 10-second cycle time between samples.
UV-Visible Spectrophotometers UV-Visible Spectrophotometers
Shimadzu has been developing UV-Vis spectrophotometers for 60 years, and continues to manufacture instruments that meet scientists' needs for ruggedness, ease of use, validation and applications. Our current lineup features the general, all-purpose UV-1800 with best-in-class resolution (1nm) and built-in biological software, introductory research-grade UV-2600, with an extended range to 1400nm, and the double monochromator UV-2700, which is capable of high Abs measurements. These compact systems are equipped with proprietary low-ray-ligh gratings, offer USB connectivity, and come with the full-featured UVProbe software.
FTIR FTIR Spectrophotometers
Whether you are looking for a simple instrument for a teaching lab or a sophisticated research instrument, Shimadzu can provide you with a high-performance option. Combining high speed, best-in-class 60,000:1 S/N ratio, and excellent resolution with enhanced expandability and easy-to-use software, the IRTracer-100 quickly and easily obtains high-quality data for a wide range of samples. Designed with the teaching and general research laboratories in mind, the compact, robust IRAffinity-1s FTIR is ideal for high-precision infrared analysis to confirm, identify, and detect foreign matter in a multitude of application areas.
Particle Analyzers Particle Analyzers
From dense to super-fine particles, Shimadzu has the high-performance Particle Size Analyzer for applications in pharmaceuticals, metals, minerals, cosmetics, food, civil engineering, the environment and more.
X-ray X-Ray Instruments
Energy Dispersive X-ray (EDX) fluorescence spectrometry is used to perform qualitative and quantitative analysis of samples by measuring re-emitted characteristic X-rays from elements. The ideal tool for non-destructive applications, EDX allows measurement of a wide variety of sample types, such as solids, powders, and thin films, in many different applications areas, including electronics, chemicals, and foods.
Fluorescnce Fluorescence
Fluorescence is typically 100 to 1000 times more sensitive than traditional absorption techniques. Providing enhanced sensitivity and dynamic range the RF-6000 Spectrofluorometerenables a wide-range of Luminescence measurement techniques including Fluorescence, Phosphorescence, Bioluminescence, Chemiluminescence, and Electro-Luminescence. Application areas include Pharmaceuticals, Life Science research, Chemicals, Environmental, Foods, and Electrical/Electronics.
Balances Balances
Shimadzu has introduced user-friendly instruments and features to the market, such as: the temperature-based fully-automatic calibration in 1985, the first one-piece force cell (OPF, later renamed UniBloc) in 1989, the high-sensitivity AEM-5200 Micro Balance in 1993, and the unique Windows® Direct feature perfectly suited for the computerized laboratory of the 21st Century. Moving forward, Shimadzu is committed to providing innovative products for the analytical marketplace. Learn more now.
Edman Chemistry Protein Sequencer Edman Chemistry Protein Sequencer
Protein sequencing via automated Edman degradation chemistry remains a simple and robust solution for many labs, delivering unambiguous data that is much less complex than the data obtained through mass spectrometry-based techniques.