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Impurity and Degradant Studies

Identification and analysis of impurities and degradants is crucial to reaction monitoring, stability testing, and patent protection. LC/MS is often the analytical technique employed for this task because of its high selectivity and sensitivity, although NMR and IR may also be used for further structure elucidation. Software can assist with processing, managing, and reporting LC/MS, NMR and IR data for impurity and degradant studies.

Accelerate LC/MS Data Processing and Interpretation

Advanced LC/MS processing algorithms can help users confidently extract trace components from the background noise and eluent signals, and identify differences between samples due to changes over time. Automatic assignment of MS fragments gives users a head start on the analyses of observed fragmentation patterns, and lets them obtain insight into the possible chemical structure of an unknown degradant or impurity.

Relevant Links: Analysis and Processing of Spectroscopic Data, Advanced Processing Algorithms for LC/MS and Structure Elucidation by MS.

Streamline Information Management with a Single Software Platform

A large amount of information can be collected over the course of impurity or degradant studies. It is necessary to keep track of compounds associated with a reaction, along with associated analytical data, and also be able to access this information several years later in the manufacturing stage. How can this information from different sources be efficiently organized and distributed? ACD/Labs' software provides a single software platform that can:

  • Manage interconnected HPLC, MS, NMR, and UV data, with fully or partially elucidated chemical structures, in one homogeneous platform.
  • Build reaction maps to visually link structures of products with observed impurities or degradants, and incorporate other information, such as reaction rates.
  • Provide shared access to experimental data, methods, and results through a corporate intranet for authorized personnel and sites.

Relevant Links and Software: Read more about how to organize and access data on the analytical informatics and data management solution page. For more information about creating and storing reaction maps, visit the ACD/ChemFolder product page.

Eliminate Repeated Experiments and Instrument Downtime When Developing Chromatographic Methods

The separation and purification of compounds can be challenging if new methods have to be developed or older ones modified. Speed up this chromatographic method selection and component identification through searches involving various criteria such as pre-experimental calculations, retention times, or an analyte structure.

Read more about solutions for chromatography.

Facilitate Communication of Results with Advanced Reporting Tools

Reporting results is a necessary yet tedious part of the scientific process. A single software package that allows you to assemble data from different sources in a uniform way can be very helpful. All of ACD/Labs' software applications work seamlessly with Microsoft® Office products to help you format your spectra, tables, and structures without the formatting headaches. For more information about how software can simplify the creation of reports, click here.

Develop Efficient Stability-Indicating Methods

The development of stability-indicating methods can be difficult and time-consuming due to the large amount of samples and experiments generated over the course of the study. ACD/Method Development Suite for LC/MS can help you develop better methods, faster.

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This page was last updated 02 August 2007
 

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