Application Notes: General

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.

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.

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