ESA Biosciences Knowledge Center
ESA Biosciences provides novel products and services with an understanding of the scientific needs of customers and 40-year expertise in small molecule and biomolecule detection. We design and manufacture specialty HPLC detectors, including the Corona charged aerosol detector and Coulochem III and CoulArray electrochemical detectors; HPLC instruments, reagents, consumables; as well as turnkey systems that scientists need to achieve maximum performance. ESA – a Dionex Company is a full service, ISO-certified and FDA-registered supplier to the pharmaceutical and life science industries.
Quick Facts
ESA - A Dionex Company
22 Alpha Rd
Chelmsford, Mass. 01824
USA
www.esainc.com
info@esainc.com
Phone: 978-250-7000
Fax: 978-250-7090
Table of Contents
Webcasts
Webcast: Quality by Design and Product Purity: Breaking through Standard Method Validation with the Corona CAD Universal HPLC Detector
By ESA - A Dionex Company
Watch this webcast to learn how a new universal HPLC detector, the Corona CAD, has been evaluated for the development of validated methods by several pharmaceutical and biotech companies. Details of the validation of methods will be presented for two sample sets: accurate measurements of a traditional small molecule drug substance, and impurity determinations of a peptide drug product formulated in a mixture of lipids and phospholipids. The Corona CAD methods were rigorously and successfully validated against standard method validation criteria. The data presented here demonstrate that not only can validated methods be developed using the Corona CAD, but that the Corona CAD enables previously difficult analyses, saving time and resources.
Back to TopVideo
New CAD Allows Analytical Scientists to Get the Most from UHPLC
By ESA - A Dionex Company
Many manufacturers are turning to UHPLC for its sensitivity and reliability over conventional technologies. ESA Biosciences has married its Corona Ultra charged aerosol detector with UHPLC to provide a fast, reliable, and comprehensive solution for API and cleaning validation monitoring, mass balance work, and many other applications. It’s the “universality” of the solution—the ability to detect impurities that UV and other technologies do not—that sets the Corona Ultra apart, says John Waraska, ESA’s director of strategic marketing for life sciences.
Back to TopWhite Papers
Use of Charged Aerosol Detection (CAD) with HPLC for Analysis from Formulation to Packaging
By ESA - A Dionex Company
Different levels of components or impurities and lot-to-lot variability in ingredients can lead to significant issues. Products formulated with solvents or excipients are capable of releasing compounds from packaging materials. HPLC with CAD provides a more complete view of the data since the CAD response has less solvent interferences and does not require the presence of chromophores for detection.
Use of Universal HPLC Detection for Cleaning Validations
By ESA - A Dionex Company
Several methods and traditional cleaning solvents for manufacturing devices spiked with typical drug substances and impurities were measured using HPLC-UV and CAD detection. HPLC with CAD provides a more complete view of the data since the CAD response has less solvent interferences and does not require the presence of chromophores for detection.
Development and Validation of a Corona CAD Method for Simultaneous Determination of Peptides, Lipids and Lipid-Impurities in the Synthetic Pulmonary Surfactant Formulation Surfaxin
By ESA - A Dionex Company
Rigorous validation of an analytical method utilizing the Corona CAD for measuring major components and impurities in a peptide/lipid drug product formulation is presented in this white paper by ESA Biosciences, Inc. The Corona CAD met or exceeded specification requirements (precision, ruggedness, LOQ, etc.). Implementation resulted in significant time and cost savings for the researchers as sample preparation was greatly simplified and a number of analyses were able to be performed simultaneously.
Degradation Studies of Neuroactive Drugs by HPLC with Charged Aerosol Detection
By ESA - A Dionex Company
Many neuroactive drugs exhibit complex patterns of degradation and metabolism. To better analyze the stability and degradents of these drugs, the Corona CAD universal HPLC detector was used to monitor the peroxide-induced degradation of several neuroactive drugs. The Corona thoroughly analyzed all degradants, regardless of structure, gave excellent mass balance results, and identified impurities unseen by conventional UV detection.
Characterizing Lot-to-lot Differences in Polysorbate Samples with Universal HPLC Detection
By ESA - A Dionex Company
Impurities and lot-to-lot variability in non-UV chromophore-containing excipients and surfactants can lead to significant issues for the development of a pharmaceutical preparation. In this study, a universal HPLC detection technology, charged aerosol detection, is used to easily and clearly differentiate and identify lot-to-lot variances in a series of polysorbate preparations. Utilizing CAD technology provides laboratories with a powerful new tool in analytical capabilities for these difficult to analyze polydisperse, heterogeneous mixtures.
Applying Universal HPLC Detection to Measure Proteins, Peptides and Amino Acids
By ESA - A Dionex Company
Measurement of biologics is becoming increasingly important to the pharmaceutical industry as many new therapeutics based on proteins or peptides are being brought to market. Analytical techniques to measure ever more sophisticated protein/peptide therapeutics and their formulations are in great demand. Charged Aerosol Detection for HPLC has been shown to be capable of measuring various types of biological molecules in a sensitive, accurate and comprehensive fashion.
Applying Universal HPLC Detection in Pharmaceutical Development and Manufacturing
By ESA - A Dionex Company
Until recently, the lack of a universal HPLC technology forced pharmaceutical R&D and QC scientists to tackle many detection challenges using a combination of technologies. Now, Charged Aerosol Detection can help scientists overcome analytical problems in method development and transfer, degradation studies, formulation and excipient characterization as well as cleaning validation.
Back to TopApplication Notes
Non-Ionic Surfactants: Polysorbate 20, Polysorbate 80 and Triton X100
By ESA - A Dionex Company
This application note describes the measurement of polyethylene glycol (PEG) derivatives including Polysorbate 80 (Tween 80), Polysorbate 20 and Triton X100. The method has excellent sensitivity and a dynamic range of ng to ug levels.
Taxanes - Taxol (Paclitaxel) and Taxol B (Cephalomannine)
By ESA - A Dionex Company
This application note describes the measurement of taxanes: Taxol (Paclitaxel) and Taxol B (Cephalomannine). The method has a limit of detection of about 5 ng on column, excellent precison and a dynamic range from ng to ug levels.
Using UHPLC and Corona ultra Detection to Shorten the Analysis Time of Excipients
By ESA - A Dionex Company
This application note is for low nanogram analysis of PEG 400. Separation can be obtained by either HPLC or UHPLC with Charged Aerosol Detection. The UHPLC method offered a four-fold decrease in analysis time and solvent consumption.
Rapid Analysis of Antibiotics and Impurities by UHPLC and Corona ultra Detection
By ESA - A Dionex Company
This application note describes the use of the Corona ultra with UHPLC allows for both rapid and sensitive detection of Aminoglycoside antibiotics (e.g., amikacin, tobramycin, and neomycin). This application demonstrates a range of four orders of magnitude and detects potential impurities of these compounds.
Simultaneous Measurement of APIs and Counter-ions by UV, CAD and MS
By ESA - A Dionex Company
This application note describes the use of Corona Charged Aerosol Detector in conjunction with UV/Vis and Mass Spectroscopy allows the simultaneous analysis of both the API and counter-ion and permits the determination of organic and inorganic impurities.
Benzodiazepines and Degradants
By ESA - A Dionex Company
This application note describes the use of the Charged Aerosol Detection (CAD) for the measurement of benzodiazepines, and illustrates its ability to simultaneously measure low level contaminants and breakdown products. The method has a limit of detection of ~5-10ng on column, shows good precision [%RSD (n=5) 0.6-1.2 (200ng on column), 0.4-0.9 (2μg on column)] and has a dynamic range from ng to μg levels.
Routine HPLC Determination of Aminopyridine Compounds with a Boron-Doped Diamond Electrode
By ESA - A Dionex Company
This application note describes a sensitive HPLC-based method for the simultaneous measurement of genotoxic 2-, 3- and 4-AP using electrochemical detection on a novel BDD working electrode.
Measurement of Genotoxic Alkyl Tosylates Using the Boron-Doped Diamond Electrode
By ESA - A Dionex Company
This application note describes the measurement of the alkyl tosylates, which are undetectable by other carbon-based working electrodes, can be accurately and precisely determined to levels of 200 pg on column by the HPLC-BDD method presented in this application note.
Simultaneous Determination of Several Antibiotics: Application to Human Plasma Extracts, and Impurities and Degradants in Drug Preparations
By ESA - A Dionex Company
This application note describes a gradient HPLC-EC Array method for the determination of beta-lactam and macrolide antibiotics. The method has low pg sensitivity, a wide dynamic range, excellent linearity and demonstrates the determination of vancomycin, azithromycin, clindamycin, erythromycin, oleandomycin and amoxicillin in extracts of human plasma. Impurities and degradants in pharmaceuticals were determined at the 0.1% level.
Rapid Analysis of Gentamicin Comformers and Impurities by UHPLC and Corona ultra Detection
By ESA - A Dionex Company
This application note demonstrates the analysis of the gentamicin complex, impurities and degradents. The method requires no derivitization or the use of PAD. Using HPLC and charged aerosol detection with standard chromatography, the method requires no derivitization, special columns or post column addition. It is suitable for manufacturing or final product testing.
Back to TopProducts
New UHPLC Detector: Corona Ultra
By ESA - A Dionex Company
The new charged aerosol detector that is now truly UHPLC compatible. With reduced peak dispersion and 100 Hz acquisition rate, this detector is suited for diverse applications from small molecules and carbohydrates to lipids and polymers. With 1 second peak widths at base at 0.2 – 2 mL/min and run times at least 5 times faster than conventional systems, the Corona ultra delivers reduced time for method development, increased throughput and approximately 5 times lower solvent consumption. Typical sensitivity of <10ng on column and even as low as 500 pg on column for carbohydrates make the Corona ultra the first choice for analytical R&D through manufacturing QC.
Back to TopCase Studies
Analysis of Extractables/Leachables in Pharmaceutical Devices
By ESA - A Dionex Company
Presented here are data for two different pharmaceutical samples using CAD, with an inline UV to demonstrate applicability.
A “Global” Method for the Determination of Tissue Thiols, Disulfides and Thioethers Using an HPLC System Incorporating a Novel Boron-Doped Diamond (BDD) Detector
By ESA - A Dionex Company
Presented here is a preliminary method illustrating the ability to separate and detect a number of thiols, disulfides and thioethers in under 30mins. Peak authenticity was evaluated by spiking samples with external standards and by treatment of the plasma sample with the reducing agent tris[2-carboxyethyl phosphine] [TCEP] to convert disulfides into thiols.
Profiling and Characterization of N-and O-linked Glycans Released from Glycoproteins using PGC RP-HPLC with Charged Aerosol Detection and Mass Spectrometry
By ESA - A Dionex Company
427.93N-and O-linked glycans, released from Bovine Fetuin and other glycoproteins, were profiled by PGC RP-HPLC with Charged Aerosol Detection (Corona CAD), and characterized simultaneously by on-line mass spectrometry (MS).
Impurity Testing with the Corona CAD
By ESA - A Dionex Company
This study evaluated the Corona CAD’s analytical performance using four examples of APIs with impurities from 0.005 to 10% level.
Simultaneous Cation and Anion Analysis with Charged Aerosol Detection
By ESA - A Dionex Company
In this study, hydrophilic interaction chromatography (HILIC) was used in combination with charged aerosol detection (CAD).
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