Thermo Scientific Dionex Corona ultra RS Charged Aerosol Detector

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Application solutions Pharmaceutical Analysis Product Characterization The Corona ultra RS detector makes it easy to determine the concentration and purity of any non- and many semivolatile active pharmaceutical ingredients (APIs) and excipients. With response independent of the chemical nature of the analyte, almost any API or compound used in the formulation can be measured with predictable response. 28 DL-Leucine D-Phenylalanine Typical Pharmaceutical Agents 5 overlaid concentrations from 11–170 ng Acetaminophen Theophylline -2.8 0.12 1 2 3 3.95 Minutes Erythromycin Naproxen Na Diclofenac Na Dodecylsulfate Na Progestrone Using the unique Thermo Scientific Acclaim Trinity P1 column and the Corona ultra RS detector, the API, counterion, and impurity ions can all be quantified, simultaneously. This speeds up selection of counterions in the development process. 10.5 Sodium API and Counterions Chloride Diclofenac 0.15% Chloride Spike 0.1% Chloride Spike No Spike -5 0 1 2 3 4 5 Minutes Cleaning Validation Cleaning validation can be both difficult and time consuming. Using the Corona ultra RS detector, it is possible to measure the API and cleaning agents, either separately or together, as well as estimate their relative amounts. A profile representing the relative amounts of cleaning agent can be generated even without knowing the identity of the components. 110 –10 Typical Cleaning Agent 0 1.3 2.5 3.8 5.0 6.3 7.5 8.8 10.0 Minutes 10
3.0 0.1% PEG Pegylated Protein PEG-MAb 50 µg o.c. Biopharmaceutical Analysis Analysis of biopharmaceuticals present new challenges. Complex mixtures of large and small molecules, many without chromophores, can be analyzed using charged aerosol detection. 50 Cationic Cell-Penetrating Peptides MPG Transportan Syn B1 0 1 2 3 4 5 6 7 8.2 Minutes 50 2.0 1.0 6.09 pA 0.3% PEG 0.2% PEG 0.1% PEG 0 10 20 Minutes Fast-Acting Insulin Unknowns 0.53 10.23 Minutes 12.96 Insulin PEGylated MAb PEGylation helps the biological stability of therapeutic monoclonal antibodies (MAbs) but measuring the residual PEG can be difficult. With predictable response irrespective of the analyte, charged aerosol detection can be used to measure residual PEG in PEGylated proteins. With its sensitivity and dynamic range, both low levels of the PEG impurity and the high levels of PEGylated protein can be measured together, without the need to reanalyze the sample. siRNA Delivery Vehicles The use of siRNA as a therapeutic agent requires optimized delivery vehicles. The detector lets you measure the purity and stability of both lipids and peptides used in these delivery systems. Final Product Purity Charged aerosol detection is ideal for peptide and protein analysis. With no restriction on solvents, as with UV, this detector gives you a greater range of selectivity. And you never need worry about acetonitrile shortages again! From raw material qualification to final product purity of large or small molecules, the Corona ultra RS detector lets you see things as you have never seen them before. 0 -5 0 2 4 6 8 10 12 14 16.1 Minutes 11
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Thermo Scientific Dionex Corona ultra RS Charged Aerosol Detector

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