During this webinar we will describe the newest breakthrough technologies and applications of Raman, Laser based Infrared and UV-Vis Spectroscopy in Pharma.
This will include use of transmission Raman as an alternative to UPHPLC for content uniformity and polymorph studies. Furthermore, use of a next generation IR instrument using a quantum cascade laser will be described for chemical imaging studies including analysis of tablet component distribution, polymorph distribution, salt exchange and stability studies. New breakthrough technologies for ultra-fast and productive parallel temperature based kinetic studies, protein folding, DNA melting and other temperature related UV-Vis measurements will end this overview.
Speaker
Jan Wülfken Product Specialist – Molecular Spectroscopy Agilent Technologies
Dr. Wuelfken has worked for many years as Product Specialist for Agilent Technolgies in many region of the world, supporting Molecular ( Raman FTIR, Fluorescence nad UV-Vis/NIR) Spectroscopy business.
In the first half of this webinar, we will introduce the ICH/USP regulation and how to measure elemental impurities with the Agilent ICP-OES and/or ICP-MS instruments.
The second part of the webinar will focus on the Agilent software compliance solutions where you will see our options for data integrity as well as software features that simplify validating methods according to ICH/USP.
Speakers
Uwe Noetzel EMEAI Technical Coverage and Solutions Agilent Technologies
Uwe joined Agilent as a GC/LC MS specialist in 1989. Since 1994 he is involved in ICP-MS as a Product Specialist. In 2001 he became part of the Agilent International Distributor Organization (IDO). Today his responsibility is the full Agilent Atomic Spectroscopy Portfolio in IDO
Andrew Brotherhood
Atomic Spectroscopy Application Engineer
Agilent Technologies
Andrew has over 15 years’ hands-on experience with ICP-MS, ICP-OES and Ion Chromatography instrumentation. He has mainly worked in the pharmaceutical analysis industry gaining significant experience with developing and validating methods to pharma regulations. Andrew started working for Agilent as a full time employee in January 2018 working as an Atomic Spectroscopy Application Engineer based at the Agilent Centre of Excellence in the UK.
Organic solvents constitute a major fraction in the synthesis of pharmaceutical products. The manufacturing process for active pharmaceutical ingredients (APIs) may contribute to residual solvents remaining in the final product. Producers need to monitor and control the levels of residual solvents for several reasons—including safety, effect on crystalline form, solubility, bio-availability, and stability.
Therefore, all products must be tested to assess whether the solvents used during the manufacturing processes are within the accepted limits. Quality assurance laboratories routinely use the United States Pharmacopeia (USP) Method <467>.
Procedures for identification and quantification
The USP <467> monograph specifies the different classes of solvents per their toxicity, sets the concentration limits according to their health hazard, and describes the assay procedure for the solvents. A complete list of all the solvents that may be used in manufacturing processes is not mentioned under these classes. Therefore, the final products should be screened according to the solvents used during their specific manufacturing process.
The method is composed of three analytical procedures for identification and quantification.
Procedure A: Identification and limit testing. Uses a G43 phase (624-type column).
Procedure B: Confirms whether or not an identified solvent is above the regulated limits. Uses a G16 phase (WAX-type column).
Procedure C: Quantitative test using a G43 phase or G16 phase, depending on which produced fewer coelutions.
USP <467> analytical flowchart for residual solvent analysis.
Columns for excellent performance
Agilent J&W DB-Select 624 UI columns have shown excellent performance for residual solvent analysis according to USP <467> Procedure A. Repeatability was generally better than 2.5% RSD for Class 1, Class 2A, and Class 2B solvents. Once a residual solvent was identified above the permitted daily exposure (PDE) limit, Procedure B is performed to confirm analyte identity. The Agilent J&W DB-WAX UI GC column has been successfully used as a confirmation column, because it yields an alternate selectivity compared to that of a G43 column.
For this method, Chemetrix can recommend state-of-the-art analytical instruments. With best-in-class technology and powerful software, the Agilent 7697A headspace sampler is packed with the latest productivity-boosting features. It’s unique sampling design allows you to use hydrogen as a carrier gas, delivering optimal chromatography and helping to future-proof your lab.
Based on the Agilent Intuvo 9000 GC system, Agilent Residual Solvent Analyzers are factory pretested and preconfigured to deliver results, fast, while saving precious startup time. What’s more, their analytical precision exceeds USP method requirements for the three classes of residual solvents. It’s chemically tested to ensure optimal analysis of class 1 and class 2A/B solvents and labs can begin system calibration and validation immediately following installation.
Residual Solvent Analysis is a must in any manufacturing environment where solvents form part of the production process. Because this process is so critical, using the correct instruments suited for the lab requirements can save time and boost accuracy.
Quality control at the heart of it all
At every stage of the quality control process, Chemetrix can assist labs with full end-to-end solutions for your residual solvent analysis. Our team of qualified professionals can share a comprehensive portfolio of solutions, including different instrument models, software and consumables, that work together to provide accurate and reproducible results.
Understand what mutagenic impurities are and why it’s important to characterize and quantify them, even when present in trace amounts.
Understand the current regulatory guidelines for nitrosamines analysis in drug substance and product in Angiotensin II Receptor Blockers (sartan), ranitidine and metformin drugs
Learn about approaches for the prevention of the formation of GTIs and the confident identification and quantification of nitrosamines in APIs and drugs
Agilent Technologies understands the wide range of requirements in the geochemistry, mining and metals field. In order for you to be successful, we design our analysis instruments to operate in rugged environments at high productivity levels with minimal user training needed. Whether you are determining major or trace analytes in steel or alloy samples, determining gold, silver and platinum group elements in ore grade material, analyzing plating solutions or performing geochemical mapping, Agilent provides you with the ease-of-use and reliability required in handling the most refined and the most difficult samples. We enhance the flexibility of our instruments by offering systems that deliver higher productivity without sacrificing performance; and flexibility so you can quickly and easily handle complex matrices. Depending on sample concentrations and the number of analyses performed, Agilent offers a best-in-class system specifically designed for your needs.
In this webinar, we will look how Agilent’s ICP-OES offering can speed up your Geochemical Analysis.
The Agilent TRS100 Raman system is ideal for fast assay of tablets, capsules, and other dosage forms. Transmission Raman technology from Agilent enables simple method-development and deployment in QC applications. It is easy to implement in analytical laboratories and production areas, and has regulatory approvals for content uniformity (CU), assay, and identification (ID) applications. This online seminar provides a comprehensive introduction to the Transmission Raman technology and the Agilent TRS100 Raman system in the pharmaceutical quality-control applications.
Speakers
Yanqia Wang, PhD, Application Engineer, Molecular Spectroscopy, Agilent Technologies, Inc.
Dr. Yanqia Wang started working for Agilent Technologies Inc. as a FTIR application Engineer in 2013, providing pre-&post-sale application support. The products he covers from Bench-top FTIR microscopes to various Mobile FTIR spectrometers. Dr. Wang received his PhD of analytical chemistry from Duke University in 2004, doing dynamic IR spectroscopy research. Then he joined Fitzpatrick Center for Photonics at Duke University, doing Tissue Raman spectrometer instrumentation. Since 2007, Dr. Wang worked for Avery Dennison Corp. as a spectroscopist, providing molecular analytical support to the research & development.
Join our webinar which will guide you through efficiency gains with TOC for cleaning validation. We call it a ‘beginner’s guide’, but this webinar will benefit long-time TOC users as well as those new to using TOC for cleaning validation. We will cover step-by-step the ‘what, why, and how’ for gaining efficiency and getting the most out of TOC for cleaning validation.
In this webinar, attendees will receive an introduction to the groundbreaking Sievers Eclipse BET Platform to understand why it was created and how it works to simplify and automate endotoxin assay setup, while maintaining full compliance with USP <85>. With Eclipse, compliant 21-sample assays can be set up in as little as 9 minutes, leading to substantial efficiency gains.
This webinar will also focus on how to evaluate this revolutionary technology. From comparability of analytical results across platforms to data integrity and validation testing, this webinar will leave attendees with a solid understanding of how the Eclipse platform stacks up next to other technology on the market, and how it can be evaluated and validated in a QC lab to demonstrate viability for routine endotoxin testing.
In this webinar you’ll learn:
Why and how the Sievers Eclipse platform was developed
How the Eclipse platform increases efficiency and automates endotoxin testing
How the Eclipse platform aligns with USP <85>, EP 2.6.14, and JP 4.01
Comparability of analytical results across different platforms
Data integrity
Validation testing and validation tools available to customers
