Application Notes: General

Uncertainty in chromatographic method development and quantitative experiments often arises. RADAR can detect uncertainty, discover co-eluting compounds, collect full scan MS data and monitor the background matrix, enabling fast method development.

Ion Chromatography Applications and Detection Methods from the Thermo Scientific portfolio of products for the detection of inorganic anions and cations, toxic contaminants, and disinfection byproducts.

Determination and quantification of water contamination by phenols using the Dionex AutoTrace 280 SPE instrument.

A method incorporating direct analysis in real time (DART) ionization and Thermo Scientific™ Orbitrap™ high-resolution mass spectrometry for rapid analysis and identification of contaminating substances in water.

Specifications and data highlighting the Thermo Scientific™ Dionex™ IonPac™ CS16-4μm and CS16-Fast-4μm cation-exchange columns for the determination of disparate concentration ratios of sodium and ammonium in diverse sample matrices.

Automated Solid-phase extraction (SPE) with GC-ECD for the determination of 15 nitrobenzene compounds in finished drinking water using the automated Thermo Scientific™ Dionex™ AutoTrace 280 Solid Phase-Extraction instrument in conjunction with the Thermo Scientific™ TRACE™ 1310 gas chromatograph.

Development of an ion chromatography (IC) method using suppressed conductivity detection for the determination of Cr(VI) in drinking water.

Analysis of OCPs, PAHs and PCBs in environmental samples through a consolidated GC-MS/MS method using the Thermo Scientific™ TRACE™ 1310 GC and the TSQ™ 8000 triple quadrupole GC-MS/MS.

Reduce dissolution qualification time and improve visibility to instrument performance – see how current regulations combined with updated technology can redefine your dissolution environment!

Characterization of glycosylation is a major quality parameter in the production of biotherapeutics. This note demonstrates the benefits of using a new, small particle TSKgel Amide-80 HILIC column which improves peak capacity and sensitivity for UHPLC and LC-MS analysis of labelled glycans.

Introducing the new Verity® 1900 MS Detector from Gilson. Find out how Gilson’s solution is allowing mass detection to move into the mainstream.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) provide good manufacturing practice (GMP) guidance for the lifecycle of a product. The scope of this executive summary is to provide a brief high-level overview of GMP, the impact of PIC/S, and compliance with the PIC/S document PE 009-12 “Guide to Good Manufacturing Practice for Medicinal Products Annexes“ Annex 11 Computerized Systems.

UCT’s approach for the analysis of anabolic steroids from serum utilizes a traditional reversed phase interaction, but also features the addition of strong-anion exchange functionality (QAX) within the sorbent. This added functionality aids in the removal of unwanted matrix components commonly found in serum such as amino acids and inorganic ions. To prove the effectiveness of this approach, a comparison study was conducted using UCT’s recommended sorbent for steroid analysis (C8 + QAX) versus a traditional SLE, diatomaceous earth sorbent.

FMS, Inc. has a complete line of automated PLE solutions for extracting solids in your laboratory. Our Automated PLE solutions can improve the reproducibility of your analytical results, increase efficiency and save on operational costs, time and labor. To learn more about PLE applications for Environmental, Clinical and Food matrices. Download the Pressurized Liquid Extraction Notebook.

FMS, Inc. has a complete line of automated PLE solutions for extracting solids in your laboratory. Our Automated PLE solutions can improve the reproducibility of your analytical results, increase efficiency and save on operational costs, time and labor. To learn more about PLE applications for Environmental, Clinical and Food matrices. Download the Pressurized Liquid Extraction Notebook.

Data integrity problems in pharmaceutical quality control laboratories are driving more regulatory action than ever before. It is obvious that something has changed to drive all this activity. There is plenty of information available, but much of it seems to confuse or frustrate rather than clarify or help. In this whitepaper, we will provide clarity, dispelling confusion by looking at the facts, based on a study of available resources and direct interactions with FDA staff and their consultants. You’ll learn from Loren Smith, Agilent’s software compliance expert and a UC Berkeley instructor with 25 years of regulated software experience, how to put the current enforcement environment in historical context, and to apply critical thinking skills to what you hear or read regarding data integrity. You’ll also learn how to evaluate your current laboratory software and associated processes against these new expectations, as well as how vendors are redesigning laboratory software to help you respond to these new realities.

The introduction of UHPLC revolutionized bio/pharma analytical laboratories and advances in technology promise more for the future. In this ebook, experts explain recent advances in UHPLC, and the basics of glycan analysis. Sample preparation technologies that can increase sample throughput and improve data quality for peptide quantitation are explored. In addition, the characterization of intact antibodies using reversed-phase chromatography is detailed. Review UHPLC workflows for: • Glycan analysis • Peptides • Monoclonal antibodies

As instrumentation and analytical methods are becoming increasingly sensitive, the ability to perform trace and ultra trace analyses relies on the high quality and purity of the reagents used.

Chromatographers take great care in the selection of salts and organic solvents used in mobile phase preparation, but selecting the best type of water is sometimes an arduous task.

Ultrapure water is highly prone to contamination, e.g. it easily leaches contaminants out of container surfaces and absorbs contamination from the laboratory environment. As ultrapure water is the most frequently used solvent in any LC-MS laboratory, its purity plays a critical role in analyses. There are a number of high purity water handling pitfalls that result in degradation of its quality. To help analysts critically evaluate the potential risks involved in poor ultrapure water handling, we discuss here (I) the effect of laboratory environment and long high purity water storage, (II) the effect of the container material used to collect ultrapure water, (III) the effect of laboratory ware and equipment cleaning, and (IV) the effect of poor practices of water purification system usage.

As the sensitivity of analytical instrumentation is constantly improving, and ultra-traces of compounds are being analyzed, the purity of reagents is becoming of paramount importance. Trace impurities in the water used to prepare LC-MS mobile phases, standards or blanks may lead to erroneous results or difficulties in analyzing data.

‘Old’ HPLC methods with long run times are being altered or surpassed by newer UHPLC or core-shell methods in order to save time and cost. In this application note we show how with the use of 3 simple equations transfer of older methods can be easily achieved onto newer core-shell particles. We show the example of a pharmaceutical drug and its impurities being reduced from a 30minute run time down to less than 10minutes. Using the calculations correctly means that no loss of resolution is seen even with the decrease in retention time.