Application Notes: General
Efficient VOC Monitoring of Stack Emissions, Following European Standard Method CEN/TS 13649
October 19th 2016This application note demonstrates that Markes International’s automated thermal desorption systems offer excellent results for monitoring volatile organic compounds (VOCs) in stationary source emissions in accordance with the updated version of the European standard method CEN/TS 13649 released in 2014. The value of repeat analysis for method development and result verification is also demonstrated.
Thermal Desorption- Sensitivity, Versatility and Multiple Applications
October 12th 2016What is thermal desorption and how can it extend the capability of GC? In this podcast, you’ll hear the answers to these questions directly from Elizabeth Woolfenden, a leading expert on this sample introduction technique. As a co-founder of Markes International, widely acknowledged as the world leaders in TD, Elizabeth has been right at the heart of the development of thermal desorption, and will draw on her experience to highlight the scope of the technique, along with key technical innovations and emerging applications. So whether you’re new to TD and want a quick introduction, or an experienced analyst interested in hearing a personal perspective, don’t miss this unique opportunity to get the lowdown on thermal desorption from a major player in the area!
Disulfide Bond Mapping, Comparing Innovator and Biosimilar mAbs
October 11th 2016This application note describes a UPLC-MSE analysis of monoclonal antibody (mAb) disulfide bond. This study demonstrates that UNIFI-a compliance-ready software-is designed to support biopharmaceutical laboratories in performing fast peptide mapping and monitoring of mAb disulfide linkages.
A Basic Overview: Meeting the PIC/S Requirements for a Computerized System
October 6th 2016This 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.
Automated Extraction and Analysis of Isomeric Cortisone and Prednisolone
April 16th 2016A 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.
Automated Extraction and Analysis of Isomeric Cortisone and Prednisolone
April 16th 2016A 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.
Drug Analysis from Oral Fluids
April 16th 2016The 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.
Drug Analysis from Oral Fluids
April 16th 2016The 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 in Pharmaceutical Quality Control Laboratories: What You Need to Know Q&A Part 2
April 15th 2016Data 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.