PHARMACEUTICAL
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Manufacturing and QA/QC
Process for production, Quality control & assurance
Shimadzu solutions for pharmaceutical manufacturing QA/QC cover a broad range of
applications with fulfilling the regulatory compliance needs.
- Liquid chromatography.
- Modular types of LC (Prominence series) and integrated types of LC (LC-2010 series) provide a wide range of applications for pharmaceutical QA/QC. Prominence UFLCXR systems improve efficiency of not only dissolution testing but also method development. Automated sample preparation with Co-sense series supports impurity analysis.
- LC/MS
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The LCMS-2020 is a newly released single quadrupole mass spectrometer for Prominence UFLC system.
LCMS-2020 provides the fastest scan speed and delivers excellent sensitivity, features suitable for impurity analysis in the pharmaceutical industry. User friendly design of the hardware and software makes the LCMS-2020 an excellent choice for the QA/QC laboratory.
- Gas chromatography
- The GC-2010 Plus delivers faster analyses, reduced downtime, superior reproducibility, and excellent stability. GC-2014 is ideal for routine analyses and utilizes the high-end technology of the GC-2010 to cover a wide range of applications from capillary to packed column analysis.
- GC/MS
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The GCMS-QP2010 Plus is an ideal instrument for rapid analysis of difficult samples and determination of trace components.
World-class features include an extended mass range, best-in-class sensitivity utilizing a novel ion source (patent pending), and a high-performance split-flow TMP.
- Spectrophotometer
- Shimadzu meets your needs for ruggedness, ease of use, validation and applications with a wide selection of UV-Vis spectrophotometers.
- Spectrofluorophotometer
- Shimadzu opens up a new spectrum of fluorescence analysis with a variety of spectrofluorophotometers for applications from routine analysis to research work in pharmaceutical area.
- FT-IR
- Shimadzu FT-IR systems support the wide range of characterization applications. Many accessory devices are available depending upon the application.
- Atomic absorption spectrophotometer
- Shimadzu atomic absorption spectrophotometers are easy-to-use and feature higher sensitivity analysis suitable for the regulated environment.
- TOC analyzer
- Shimadzu TOC analyzers maximize both sensitivity and productivity, making them the ideal choice for performing validation processes to meet the required regulations in the pharmaceutical industry.
- Thermal analysis
- Shimadzu Thermal Analysis Systems offer unmatched flexibility in material characterization with either complete standalone functionality or multi-system operation for up to 4 units. Regulatory compliance is strongly supported.
- Powders & Particle Size Analyzers
- From dense to super-fine particles, the Particle Size Analyzer supports a wide variety of applications in pharmaceutical particle size analysis.
- Testing & inspection machines
- Shimadzu universal testing machines provide not only reliable data, but are convenient and easy to use for pharmaceutical production and QA/QC applications.
- Energy dispersive X-Ray Fluorescence spectrometer (EDXRF)
- EDX-720 are applicable in the element range from sodium to uranium, whereas the EDX-800HS extends the element range to include carbon.
- Balances
- Shimadzu offers a wide selection of balances to meet various user and lab environment needs.
- Data systems and data management tools
- The LabSolutuons software series is CLASS- Agent integrated data management/archiving software manages both machine-readable and human-readable data from a variety of Shimadzu instruments, including HPLC, GC, UV-Vis, TOC, and Balances. The ideal solution for you analytical laboratory, CLASS-Agent manages your data with ease while providing a scalable solution to 21 CFR Part 11 compliance requirements.
- Regratory compliance total support
- In addition to providing products lineup, Shimadzu supports documentation of management procedure and operation for Part 11/CSV (Computer System Validation) compliance.
