Shimadzu

LabSolutions Insight Biologics is a dedicated software platform for oligonucleotide characterisation using the LCMS-9030 or LCMS-9050 quadrupole time-of-flight mass spectrometer (Q-TOF). Identification of major products and impurities involves multiple core editors for sequence, nucleotide, linker, ribose and base modifications. In addition to the processing and integration of target modifications, Insight Biologics is also a comprehensive workspace for data review, processing and reporting.

Insight Biologics provides an easy way to enter sequence information, configure target modifications and set data analysis parameters. It uses sequence information to comprehensively identify chain length differences, nucleotide gaps, modifications, transformations, adducts and other impurities. Q-TOF data-dependent acquisition (DDA) records MS and MS/MS spectra. The MS spectrum is used to identify the molecular weight of the impurity, and the corresponding MS/MS fragment spectrum is used to confirm the sequence. Visual representation of sequence coverage increases identification certainty. Seamless processing and reporting and audit trail support make Insight Biologics a comprehensive solution for oligonucleotide characterisation.

LabSolutions Insight Biologics | SHIMADZU EUROPA

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LabSolutions Insight Biologics, a complete workflow from data acquisition to analysis and reporting! Your dedicated workspace for oligonucleotide characterisation.

LabSolutions Insight Biologics

An automated solution for Analytical HPLC Method Development following AQbD principles

The LabSolutions MD support software for analytical HPLC method development and optimization follows the “Quality-by-Design” principle using Design of Experiments (DoE). In combination with the Nexera UHPLC Method Scouting System, it offers a graphical user interface to simplify the system setup, as well as automated batch creation, to provide reliable data while minimizing the risk of human error. It enables screening of various combinations of different mobile phases and separation columns to rapidly identify a suitable combination visually and quantitatively according to specified parameters, such as number of separated peaks and resolution. With the selected combination, LabSolutions MD can then create a multifactorial experimental design, where using only limited input data, the software is able to determine optimum separation conditions within the design space. Accurate retention modelling allows an estimation of method robustness in minimal time.

LabSolutions MD, in combination with the Shimadzu LabSolutions chromatography data system (CDS), provides data management, statistical evaluation and intuitive reporting, all in a LabSolutions database, ensuring data integrity.

The perfect complement for the Nexera Method Scouting System: LabSolutions MD, the first software to integrate all phases of HPLC method development following an Analytical Quality by Design approach.

The Fine Art of Method Development

Designed in collaboration with the Enabling Technologies Consortium (ETC), the award-winning Nexera UC Prep SFC is a next-generation solution to the demand for efficient and robust semi-prep SFC purification in the pharmaceutical, chemical and food industries. Its flexible system configuration in a compact design allows users to overhaul their workflow, reduce inefficiencies and meet a wide range of purification requirements.

With unparalleled performance and flexibility, the Nexera UC Prep resolves several known issues of preparative work and improves efficiency, while fitting into pre-existing workflows. It provides flexible system configurations in a compact design, requiring low installation space and allowing to maximize lab resources.

SFC is a green technology that reduces the need for costly and hazardous solvents, while shortening purification and dry down time, and the novel gas-liquid separator technology, “LotusStream”, ensures higher recovery and lower carryover than earlier cyclone-style or centrifugal type gas-liquid separating systems.

The newly developed, easy-to-use preparative software, “Prep Solution”, streamlines operations. It simplifies configuration of parameter settings and greatly increases the efficiency of the preparative workflow.

https://www.shimadzu.eu/prep-for-the-future 

Shimadzu’s Nexera UC Prep semi-preparative SFC system reduces labor and improves efficiency, while fitting into pre-existing workflows. Flexible configurations ensure optimum performance for a variety of purification tasks.

Shimadzu's Novel Semi-preparative Supercritical Fluid Chromatography System

This application demonstrates the advantage of coupling LC-MS to a HPLC-UV system for highly sensitive (pg level) and selective quantitative analysis in cleaning validation. 

Using a Highly Sensitive and Selective Single-Quad LCMS for Cleaning Validation

The i-volution in HPLC analysis continues

The advanced i-Series of compact (U)HPLC systems has evolved to include Analytical Intelligence in the LC-2050 HPLC and LC-2060 UHPLC systems. The products combine high-speed analysis, simplified method transfer, automated sample pre-treatment, minimized environmental impact and easy maintenance with the flexibility of working remotely.

The original i-Series liquid chromatograph combines superior basic functions and high-speed analysis in a compact table-top system, and its excellent usability significantly reduces the burden on the operators. These features have led the i-Series to be adopted worldwide for quality control, specification testing and R&D purposes in a wide range of fields such as food and environmental science, chemistry and particularly in the pharmaceutical industry.

Retaining the excellent basic functions of the compact “i-Series” instruments, the Advanced i-Series boasts increased pressure resistance and Analytical Intelligence features to support remote work. It addresses the demands of an increasingly varied range of users, locations and approaches to analysis while always delivering highly reliable analytical results. Use of the Advanced i-series is intuitive and user-friendly, for reliable, reproducible data, independent of the analyst’s experience level. Analytical Intelligence enables higher productivity, maximum reliability and better connectivity.

The i-Series of compact (U)HPLC systems has evolved to include Analytical Intelligence to combine high-speed analysis, automated pre-treatment, minimized environmental impact and easy maintenance with the flexibility of working remotely.

Shimadzu's i-Series of Compact (U)HPLC Systems 

Drugs containing sartan APIs (active pharmaceutical ingredients), such as valtrasan, candesartan, losartan and olmesartan, are used for treatment of hypertension and heart failure.

Recently US FDA has released finding of probable human carcinogens, N-nitrosodimehyleamine (NDMA), N-nitrosodiethylamine (NDEA) and N—N-methyl-4-aminobutyric acid (NMBA) in sartan drug products and the affected medicines have been recalled. These nitrosamine impurities can form during the production of sartans that contain a functional group known as a tetrazole ring under certain conditions. Additionally , the presence of the impurities in some sartans is possibly due to uses of contaminated equipment or reagents. To detect the presence of the nitrosamine impurities two methods based on headspace GCMS and direct liquid injection are released.

 offers high robustness and the contamination-resistant ion source with the new detector with over five times longer service. With the ultra-high-sensitivity performance of the GCMS-TQ8050 NX, injection volumes can be reduced even further than before.

LC, HPLC, UHPLC, LCMS, UFM, Spectroscopy, UV-Vis-NIR, FTIR, AAS and EDX, ICPMS, Particle Size, Life Science Lab Instruments, TOC, Material Testing and Measuring Technology.

The GCMS-TQ8050 NX offers high robustness and the contamination-resistant ion source with the new detector with over five times longer service. With the ultra-high-sensitivity performance of the GCMS-TQ8050 NX, injection volumes can be reduced even further than before.