Application Notes: General

This whitepaper provides a summary of 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 Computerised Systems. It includes a high-level foundation to understand how pharmaceutical manufacturing companies are being regulated, what PIC/S means for common requirements across different countries, and how these requirements relate to expectations for data from computerised systems/electronic records.

The quick capture and accurate titer analysis over a wide concentration range of monoclonal antibody is demonstrated using a TSKgel® Protein A-5PW, 20 μm analytical column.

Reflectron lenses are used in time-of-flight (TOF) mass spectrometers to create an electrostatic field to alter ion flow, providing for a longer flight path and therefore greater resolution.

The development of an automated online SPE–LC–MS-MS method for the analysis of 25-OH-vitamin D2, 25-OH-vitamin D3, and 3-Epi-25-OH-vitamin D3 from human serum.

Enhancing the extraction of vitamin A and E in serum using simplified liquid extraction (SLE) significantly improves the LC–MS-MS detection of target compounds without an overly complex method or sacrificing robustness.

The development of an automated online SPE–LC–MS-MS method for the analysis of 25-OH-vitamin D2, 25-OH-vitamin D3, and 3-Epi-25-OH-vitamin D3 from human serum.

A full ESI+/ESI- 52 drug panel was performed in 7 min and 30 s, including re-equilibration (44 in ESI+ and 8 in ESI-). This rapid analysis showed great resolution and no loss in sensitivity compared to slower methods.

Enhancing the extraction of vitamin A and E in serum using simplified liquid extraction (SLE) significantly improves the LC–MS-MS detection of target compounds without an overly complex method or sacrificing robustness.

A simple automated extraction method using a Tecan Freedom EVO® 100 liquid handler and Phenomenex’s Novum simplified liquid extraction (SLE) 96-well plate. Analysis of isomeric cortisone and prednisolone by UHPLC by Kinetex 2.6 μm, 50 x 3 mm core-shell Biphenyl column was used to successfully separate these two compounds and their isomers.

A simple automated extraction method using a Tecan Freedom EVO® 100 liquid handler and Phenomenex’s Novum simplified liquid extraction (SLE) 96-well plate. Analysis of isomeric cortisone and prednisolone by UHPLC by Kinetex 2.6 μm, 50 x 3 mm core-shell Biphenyl column was used to successfully separate these two compounds and their isomers.

Using a single LC–MS-MS application, 12 steroids were separated. However, three separate panels are also run as an alternative method.

This application note describes the GC¬¬–MS analysis of 23 drugs of abuse from various compound classes such as amphetamines, benzodiazepines, cannabinoids, and other illicit drugs.

A simple sample preparation procedure and a rapid, sensitive, specific UHPLC–MS-MS method has been developed for quantifying several antidepressants and metabolites.

Using a single LC–MS-MS application, 12 steroids were separated. However, three separate panels are also run as an alternative method.

A simple sample preparation procedure and a rapid, sensitive, specific UHPLC–MS-MS method has been developed for quantifying several antidepressants and metabolites.

This application note describes the GC¬¬–MS analysis of 23 drugs of abuse from various compound classes such as amphetamines, benzodiazepines, cannabinoids, and other illicit drugs.

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.

This podcast will focus on new developments involving our understanding of disinfection by products in drinking water. We will cover updates to toxicological compounds and advancements in new technologies to identify them.

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.

Explore the potential for screening human blood fortified with ethylenediaminetetraacetic acid (EDTA) via LC/MS using an expression single quadrupole compact mass spectrometer.

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.