Application Notes: General

The increased use of hormone-based therapies in health care throughout the world has resulted in hormones finding their way into municipal water supplies. The potential health risks of unintended consumption of hormones through drinking water have significantly increased the interest in identifying these compounds in our water supplies. The Milli-Q system incorporates a combination of purification processes that provides ultrapure, hormone-free lab water for the LC–MS techniques used for interference-free analysis of these contaminants.

Historically, UV detection has been favored in many laboratories for its ease of use, robustness, and reliability. However, some of the inherent challenges include analytes that do not have a response in a UV channel, coelutions, and unknowns, any of which can require an orthogonal approach such as mass detection. While mass detection offers a number of benefits when used in tandem with UV detection, incorporating it into an existing UV workflow can be time-consuming and laborious.

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 summary, 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.

Ion chromatography (IC) is a well-established technique for monitoring inorganic anions in environmental waters around the world. It is approved by the U.S. Environmental Protection Agency (U.S. EPA) for compliance monitoring of primary and secondary inorganic anions in drinking water and has been validated by European standards organizations, including the International Standards Organization (ISO). These agencies have published IC methods for the analysis of inorganic anions in drinking water, groundwater, and wastewater. These methods can be made faster and more cost-effective, however, by using the latest IC technologies, including high-pressure IC. In this summary, we will discuss regulatory compliance testing of municipal drinking water and wastewater, and how this testing can be made faster and more cost-efficient through the use of high-pressure-capable ion chromatography systems.

The objective of this application note is to demonstrate that the ACQUITY QDa Detector provides a simple and cost-effective solution for detecting oligonucleotides across a wide molecular weight range and can be readily integrated into existing UV-based workflows.

This summary will explore the latest developments in the analysis of contaminants of emerging concern in drinking water. We will explore the requirements and results from the EPA’s Unregulated Contaminant Monitoring Rule 3 program for Perfluorinated organics, and hormones. After a brief overview of the EPA analytical techniques, we’ll take a look at new technology and ask how it compares for both and if it can find compounds we didn’t even know were there.

The validation process of an analytical method is a complex and demanding activity, consisting of many time-consuming steps. Empower® 3 Method Validation Manager (MVM) automates the method validation workflow within a single software environment, reducing time and ensuring conformance to the validation requirements and acceptance criteria defined in the protocol. This application note demonstrates validation of a UPLC® method for metoclopramide HCl and related substances using Empower 3 MVM.

Hamilton polymeric PRP-X100 and PRP-X110 anion exchange columns are the easy way to separate inorganic and organic anions from 10 ppb to 500 ppm without elaborative preconcentration or suppression.

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.

A method for the determination of pyrethroids in water at ultra-low-level concentrations of 0.02 and 0.10 ng/mL was developed using solid-phase extraction (SPE) for pre-concentration and subsequent analysis by GC with PTV injection.

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.