Restek Offers the Latest USP <467> Class 2 Residual Solvents for Pharma Analysis

Restek is a long-time partner of pharmaceutical QC labs performing residual solvent analysis, and our support continues with the release of an updated Class 2 Mix A reference standard. This standard has been reformulated to include cumene, which was added to the USP Class 2 list in August 2013, and allows labs to successfully detect and quantify solvent residues in compliance with the latest USP <467> guidelines.

As with our other USP <467> mixes, this standard is prepared with the superior quality and reliability you have come to expect from Restek. It is quantitatively tested to confirm composition and stability, and detailed documentation is provided. In addition, being manufactured and QC-tested in Restek’s ISO-accredited labs means this standard will also help satisfy strict ISO requirements for the use of certified reference materials (CRMs).

Restek is your complete supplier for world-class USP <467> residual solvent analysis. Get the up-to-date reference standards, Rxi®-624Sil MS (G43) and Stabilwax® (G16) GC columns, inlet liners, accessories, and applications you need at

www.restek.com/usp467

About USP <467> Class 2 Residual Solvents:

The United States Pharmacopeia (USP) General Chapter <467> Residual Solvents is a widely used compendial method intended for identifying and quantifying residual solvents in drug substances, drug products, and excipients. This method identifies acceptable amounts of solvent residues that can be present, and the solvents are summarized by class according to their toxicity. Class 2 compounds are nongenotoxic animal carcinogens, and concentrations of these compounds should be limited. Chromatographic analysis is needed for both the Class 1 and Class 2 residual solvents. This new standard reflects the changes made in USP <467> effective August 2013 and replaces Restek® cat.# 36271.

 

The Effects of LC Particle Choice on Column Performance: Switching from 3 and 5 µm Fully Porous Particles (FPP) to 5 µm Superficially Porous Particles (SPP)

Author(s): Sharon Lupo, Ty Kahler, and Paul Connolly
Restek Corporation

Published By: Restek Corporation

Year of Publication: 2014

Link:  http://www.restek.com/Technical-Resources/Technical-Library/General-Interest/general_GNAR2109-UNV

Abstract: In this technical note, we will compare the performance of Raptor™ 5 µm superficially porous particle (SPP) LC columns to traditional 3 and 5 µm fully porous particle (FPP) LC columns. We will demonstrate how faster, more efficient analyses can be attained with greater sensitivity and reduced system pressure by switching from FPP to SPP—without altering method conditions.

Impact of GC Parameters on the Separation Part 3: Choice of Column Length

Author(s): Jaap de Zeeuw
Restek Corporation

Published By: Separation Science

Year of Publication: 2014

Link: http://www.sepscience.com/Information/Archive/All-Articles/3352-/Impact-of-GC-Parameters-on-The-Separation-Part-3-Choice-of-Column-Length

For the full print issue, visit http://www.sepscience.com/docs/Articles/Oct2014/SepSci1014_NA.pdf?utm_source=iContact&utm_medium=email&utm_campaign=eLearning%20Newsletter%20-%20North%20America%20Sep%20Sci&utm_content=

Abstract: In Parts 1 and 2 of this series, we focused on the selection of stationary phase and looked at different applications for using different internal diameters. Capillary columns are also available in different lengths. Here we look at the third parameter: column length. What is the impact of column length on the separation? If the length is changed, what do I have to do to get the results that I anticipate?

Storage Stability of 66 Volatile Organic Compounds (VOCs) in Silicon-Lined Air Canisters for 30 Days

Author(s): Jason S. Herrington, Ph.D.
Restek Corporation

Published By: Restek Corporation

Year of Publication: 2014

Link: http://www.restek.com/Technical-Resources/Technical-Library/Air-Sampling/env_EVAN2066-UNV

Abstract: The recoveries of 66 volatile organic compounds (VOCs) typically analyzed as part of the EPA Method TO-15 were evaluated for two commercially available silicon-lined (SL) air canisters. For the majority of the 66 VOCs, there were no appreciable differences in recoveries and stabilities between the canisters for both dry and humid conditions over 30 days of storage. Acrolein, dibromochloromethane, and bromoform were the only three compounds which appear to be unstable in both SL canister types; however, only under the humid (93% RH) condition.

Restek® MXT® Columns and the Rosetta Spacecraft Make Headlines From Space

MXT Columns in SpaceThe European Space Agency (ESA) once again made the news when, awaking after 31 months of power-conserving hibernation, its Rosetta spacecraft sent a signal from beyond Jupiter to ESA’s mission control center in Germany. Already almost 500 million miles (800 million kilometers) away from Earth, Rosetta began its journey in 2004 and, this August, will finally reach the Comet 67P/Churyumov-Gerasimenko, which it will follow, study, and even land on. To accomplish its pioneering two-year research mission, Rosetta’s orbiter and lander carry a total of 21 scientific instruments, and Restek couldn’t be more proud that these instruments feature not one, but four MXT® GC columns.

Restek’s MXT® gas chromatography (GC) columns are made for environments with extreme temperatures and situations where the potential for column breakage is too high to rely on fused silica. In other words, whether your analysis is being done in the field, the refinery, or the farthest reaches of the solar system, our metal capillary columns are the reliable choice for great data. Other companies who developed products for the Rosetta mission are no longer in business, but Restek and our rugged MXT® columns are both still going strong.

According to Robert Sternberg, who was responsible for the space GC team at Laboratoire Interuniversitaire des Systèmes Atmosphériques (LISA) of the University of Paris XII:

” I would like to mention that all the columns selected for space mission are Silcosteel®-treated metallic capillary columns, and they have all been submitted successfully to space qualification tests such as vibration, radiation, and thermal cycles1, which demonstrated their robustness for space application.

Since the beginning, the Restek company has been more than a manufacturer providing LISA with columns. Indeed, it has been strongly collaborating and helping LISA to develop custom-made columns able to meet the requirements of such an unusual scientific goal for chromatographic columns. That is why LISA is very grateful to Restek for being this ideal partner without the help of which the study and development of chromatographic columns for space use could not have been possible.”

You can follow the accomplishments of the Rosetta craft and its on-board MXT® columns on Twitter at @ESA_Rosetta

Visit www.restek.com/mxt to learn more about MXT® columns and put one to the test today.

1C. Szopa, U.J. Meierhenrich, D. Coscia, L. Janin, F. Goesmann, R. Sternberg, J.-F. Brun, G. Israel, M. Cabane, R. Roll, F. Raulin, W. Thiemann and C. Vidal-Madjar and H. Rosenbauer J. Chromatogr. A, 982 303-312 (2002)

Impact of GC Parameters on the Separation Part 2: Choice of Column Internal Diameter

Author(s): Jaap de Zeeuw
Restek Corporation

Published By: Separation Science

Issue: vol. 6, issue 4

Year of Publication: 2014

Link: http://www.sepscience.com/Information/Archive/All-Articles/3351-/Impact-of-GC-Parameters-on-The-Separation-Part-2-Choice-of-Column-Internal-Diameter

For the full print issue, visit http://www.sepscience.com/docs/Bespoke/Editions/SepSci/SepSci_0714.pdf

Abstract: In Part 1 of this series, we focused on how to select the stationary phase, which is one of the seven important parameters we need to understand. Once the most interesting stationary phase is selected, the column dimensions must be considered. Here column length, diameter, and film thickness are the key parameters. In this article, we turn our attention to the column internal diameter and its relevance.