Application Notes

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.

In new drug development, the number of diverse chiral compounds is increasing and sensitive chiral methods are often needed quickly. Many new CSPs are available on the market making it challenging to select the most important ones for the initial screening stages and expedite method development. The focus of this study is to evaluate high selectivity CSPs and to suggest the best screening method with a limited number of high success rate chiral columns.

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.

‘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.

This Application Note demonstrate ultrafast gradients with an over 60 % reduction of analysis time using the Agilent 1290 Infinity II Multisampler with dual-needle function and alternating column regeneration.

This Application Note demonstrate ultrafast gradients with an over 60 % reduction of analysis time using the Agilent 1290 Infinity II Multisampler with dual-needle function and alternating column regeneration.

Starch is used for a variety of industrial and nu¬tritional purposes. Its functional properties are influenced by the ratio and molar masses of its mac¬romolecular constituents, which vary with source, crop year, and climate. Starch contains large homopolymers of amylose (AMY) and amylopectin (AMP).

This Application Note describes the comparison of complex hop aroma profiles by GC–MS, and the identification of aroma-active terpenoids aided by soft electron ionisation.

This Application Note describes the comparison of complex hop aroma profiles by GC–MS, and the identification of aroma-active terpenoids aided by soft electron ionisation.

High pressures and columns with small particle sizes have been used in high-performance liquid chromatography (HPLC) for a long time, but not in ion chromatography (IC). But now, high pressures are coming to IC. Read this new e-book to learn about: • The advantages of high-pressure and small-particle-size columns in IC • How those advantages apply to real-world examples in the analysis of food, beverages, and environmental samples • The reasons why the move to high-pressures in IC has taken so long • The drivers for the trend toward higher-capacity IC columns . . . and more! Download the e-book today!

Studies of adenosine monophosphate (AMP) and phosphorylated sugar in rat blood have become increasingly important in toxicology and insulin investigation. HPLC is typically the ideal method for this study. Shodex VT-50 2D would be the ultimate column due to its cAMP and AMP capabilities.

Initial precision was demonstrated by spiking four 1-L volumes with one Snip and Pour pre-measured standard, each (40 mg). The data for four replicates was collected for 47 mm Disks and 100 mm Disks. The average percent recovery is excellent and meets the criterion specified of 83–101% HEM recovery for both size disks. The standard deviation is better than the criterion specified of 11% for HEM.

A variety of alcoholic beverages purchased within the UK were analyzed for the presence of Ethylcarbamate. A 1 µL injection of these alcoholic beverages were analyzed on an Ellutia 200 GC followed by detection on an Ellutia 820 TEA working in nitrogen detection mode. This mode of analysis detects nitrogen containing compounds within a sample. The Ellutia 810/820 systems are able to analyse various nitro or nitroso compounds, utilizing the selectivity available through nitrogen or nitroso modes. Nitrogen mode utilizes the catalytic pyrolyzer tube, oxygen reactor, and higher temperatures to detect nitrogen compounds. Results for various alcoholic beverages are shown in Figure 3. The samples were found to have various low levels of ethylcarbamate, the system was optimized through levels of oxygen input and EHT sensitivity. The samples were then analyzed adopting a standard addition approach.

Hamilton PRP-X100 and PRP-X110 are the perfect solution for anion analysis in water or environmental samples. The robust design and covalent surface modification of the packing material lead to a highly increased lifetime as compared to the competition. The production process is compliant to ISO 9001 ensuring an outstanding column-to-column and lot-to-lot reproducibility.

This application note describes the development of an analytical method for the sensitive and accurate determination of free and total thyroid hormones in serum and plasma using a mixed-mode SPE extraction procedure and UHPLC–MS-MS analysis.

The standards are commercially available from Wellington Laboratories Inc. (Ontario, Canada): TF-TCDD-MXB.

Analysis of the six matrices processed yielded acceptable recoveries for all analytes with standard deviations below 20%. Analysis of an n-hexane blank sample resulted in no detectable target analytes measured within the calibration range of each respective compound.