Application Notes: General

The collection of oral fluid is gaining popularity due to the fact that it is not intrusive and easy to use. In this study we look at four different devices, and compare the results obtained for drugs varying in terms of hydrophobicity and their acidity/basicity.

The collection of oral fluid is gaining popularity due to the fact that it is not intrusive and easy to use. In this study we look at four different devices, and compare the results obtained for drugs varying in terms of hydrophobicity and their acidity/basicity.

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.

Recently the US EPA published a list of 30 UCMR4 (the 4th Unregulated Contaminant Monitoring Rule) analytes which may potentially be present in tap water but are not yet subject to EPA’s drinking water standards set under the Safety Drinking Water Act. Four among the 30 UCMR4 compounds, including o-toluidine, quinoline, butylated hydroxyanisole (BHA), and dimethipin, are determined by EPA method 530 using solid phase extraction (SPE) and GC/MS detection. In this study, analytes were extracted using UCT’s divinylbenzene based sorbent (HLDVB). GC/MS SIM method with solvent standard calibration was carried out for data acquisition and analyte quantitation.

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.

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.