Phenomenex, Inc.

This executive summary explores how revisions to USP <621> have introduced greater flexibility in chromatographic method adjustments while reinforcing system suitability as the definitive standard for method acceptance. Heiko Behr, senior business development manager at Phenomenex, walks through key principles governing column substitution, flow rate scaling, mobile phase control, and dwell volume management during method transfer. A practical Nifedipine case study demonstrates how these allowances can be applied to reduce run times tenfold without compromising monograph-defined selectivity or compliance.

As regulatory mandates push PFAS detection limits toward single-digit PPT levels, the pervasive threat of background contamination from solvents and instrument components has emerged as a defining challenge for modern laboratories. Proper data defensibility requires a rigorous, end-to-end mitigation strategy that prioritizes the replacement of fluoropolymer materials with inert alternatives as well as the implementation of delay columns to isolate system-derived interference. Ultimately, adopting a proactive approach to workflow integrity, through the use of certified consumables and specialized tools, is essential for laboratories to stay ahead of tightening environmental standards and expanding target lists.

The study was done to validate method performance for the expanded list of PFAS compounds required by the State of California Water Resources Board for wastewater.

In this application note, we demonstrate the separation of the full suite of 40 PFAS compounds including a separation of at least 1 minute between TDCA and PFOS.

Webinar Date/Time: Tue, Jun 3, 2025 2:00 PM EDT

An optimized liquid chromatography (LC) method offers improved impurity separation, no batch reproducibility issues, and is unaffected by changes in gradient delay volume settings.

Learn the latest techniques for improved chromatographic performance and throughput of AAV analysis.

Per- and polyfluoroalkyl substances (PFAS) are exceptionally versatile chemicals and have seemingly endless applications. Due to their persistent nature; prevalence in blood, food and environment; and emerging toxicity, there is a significant concern for their presence in the human body. Analysis is especially complicated due to background contamination in laboratory supplies and system. This paper will discuss sample preparation and LC-MS/MS analysis of an expanded panel of PFAS compounds in serum.

Webinar Date/Time: Mon, Nov 18, 2024 11:00 AM EST

This technical note demonstrates the SEC-based separation and quantification of Cas9 IVT mRNA (with a total length of approximately 4500 nucleotides) and its aggregates.

SEC data demonstrates mRNA aggregate analysis for vaccine stability. Optimal separation occurs at 100 mM NaCl and low flow rates, enhancing mRNA production quality.

The data show that a separation between circular and linear plasmid DNA is possible and the performed linearization can be monitored using SEC-HPLC.

This application showcases the utility of SEC to resolve s.s. oligonucleotides from duplexes in mixtures of four oligonucleotide lengths (21, 40, 80, and 100mers).

Abacavir and Lamivudine in combination are used with other medications to treat Human Immunodeficiency Virus (HIV) infection. In this technical note, we report the separation of Lamivudine from its related chiral and diastereomeric impurities in Abacavir and Lamivudine tablets per the USP monograph. The allowable adjustments pertaining to gradient separations are highlighted together with the necessary calculations that are required for the adjusted method conditions to remain compliant with the original monograph.

The necessity to analyse drug products for nitrosamines and NDSRIs (Nitrosamine Drug Substance Related Impurities) is well documented. In this document we provide an overview of 7 of our most recent applications in this area, together with links to the relevant technical notes.

This applications notebook provides background information on GLP-1 analogues, together with information on the columns suitable for their purification and analysis. Finally it provides a range of reversed phase, size exclusion and preparative applications for a number of GLP-1 analogues.

LC-MS/MS method for low level quantitation of seven PFAS listed in the National Academies of Science and Engineering recommendations for clinical research.

Combining a Phenomenex Gemini C18 LC column High Resolution, high accuracy mass spectrometry was used to resolve interferences observed during analysis of PFAS in plasma and serum.

This white paper explores L/dp ratio for pharmacopeia allowable adjustments. It considers efficiency, explaining why L/dp ratio can be used as a proxy for efficiency, and illustrates the allowable adjustments through reviewing at a selection of different monographs.

Comparison of blood collected using volumetric absorptive microsampling (VAMS) and serum for LC-MS/MS for analysis of a comprehensive PFAS panel

This white paper provides an in depth consideration of the new European Pharmacopeia monograph for the analysis of chlorhexidine and it’s related impurities. The white paper considers both column batch variation and system dwell volume.

Webinar Date/Time: Wed, Sep 4, 2024 11:00 AM EDT

Webinar Date/Time: September 12, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Webinar Date/Time: Tue, Aug 27, 2024 1:00 PM EDT

Biozen dSEC-7 accurately resolves AAV serotypes 5, 8 and 9 monomer from aggregates in under 10 minutes with consistent results across different mobile phase conditions.

Webinar Date/Time: Thu, Jun 6, 2024 11:00 AM EDT

This application note demonstrates the applicability of the Biozen dSEC-2 column in understanding the biophysical integrity monoclonal antibodies and related proteins. The hydrophilic nature of the Biozen dSEC-2 stationary phase shows favorable aggregate profiles for forced degradation work under high salt conditions which is a known challenge when working with more hydrophobic hybrid particles for these studies.

Size exclusion chromatography, or SEC, is a technique for separating proteins and other complex biomolecules in their native forms by size using aqueous eluents. For molecules of specific molecular weight, SEC can use used to detect and quantitate aggregates, fragments, monomers and dimer. This guide provides a comprehensive application overview for Biozen dSEC-2 Size Exclusion Columns.

An understanding of analyte hydrodynamic radius (Rh), as well as size exclusion column pore size and distribution, are all critical in the understanding of how an analyte will behave by SEC. In this white paper, we will explore several protein standards with known hydrodynamic radii, and how this can be used to determine ideal size exclusion conditions for optimal method performance.