Whether you are new to practicing GC chromatography, or would like a refresher, the installation and care of your GC column is of the utmost importance.
Join us as we discuss proper column installation and handling for all Agilent GCs including the Intuvo 9000. We will also address the common modes of column degradation and some of the misconceptions that people have concerning column degradation. Lastly, we will discuss ways that you can protect and maintain your column’s lifetime and performance while minimising instrument downtime.
Mark Sinnott Application Engineer Agilent Technologies, Inc.
Mark Sinnott works for Agilent Technologies as a Technical Support Engineer in the Consumables and Supplies Division (CSD) at the capillary column manufacturing facility (the “J&W Scientific” location). In his position at Agilent, Mark performs technical support and applications assistance to gas chromatographers worldwide. He has more than 22 years of experience in gas chromatography, including environmental analysis of compounds in air, soil and water matrices, including dissolved gas analysis for the electrical industry. Mark holds a Master’s Degree in Chemistry from California State University, Sacramento, and currently resides in Sacramento.
Application Engineer Agilent Technologies, Inc.
In Ryan’s current role at Agilent, he provides application assistance and technical support for GC and Spectroscopy. He has been supporting Agilent in technical and sales roles for the past seven years. Ryan came to Agilent from industry, and has an BS degree in Biochemistry.
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.
Are you just getting started with a new column you have never used before? Are you looking for ways to help your columns last a bit longer? These are some of the most common questions asked of our HPLC columns technical support team. In this webinar, we will discuss best practices for HPLC column care, including reversed phase, SEC, HILIC and more. This will include initial equilibration, benchmarking a new column, column storage, and other tips to help make your columns last longer.
Mark Powell Application Engineer Agilent Technologies, Inc.
Mark Powell is an Applications Engineer located at Agilent’s Little Falls site in Wilmington, DE. Before joining Agilent in 2011, Mark worked in the pharmaceutical industry synthesizing, purifying and analyzing drug candidates. He provides applications assistance and technical support for Agilent’s HPLC columns and consumables.