liquid chromatography (LC)

  • Reducing Risk, Rework, and Cost Through Chromatographic Stability

    As clinical LC‑MS adoption continues to grow across toxicology, endocrinology, therapeutic drug monitoring, and metabolic testing, laboratories face an increasingly difficult challenge: delivering results that are not only sensitive, but routine, reproducible, and economically sustainable. While investment decisions often focus on mass spectrometry (MS) detection, experience across clinical laboratories shows that chromatography is frequently the…

  • The Hidden Cause of Variability in Clinical LC-MS

    When variability appears in clinical liquid chromatography-mass spectrometry (LC‑MS) data, the mass spectrometer is often the first place that laboratories look. Changes in signal intensity, quantitative drift, or failed batches are frequently attributed to detector performance, ion optics, or acquisition settings. Chromatography is often the root cause of the variability observed at the mass spectrometer….

  • Built on Control and Backed by Data: Why Vigilant Monitoring Matters in Pharma QC

    Stage 3 verification: Establishing and maintaining a state of control In pharmaceutical quality control (QC), consistency should mean more than an analyst ending a shift relieved that the results were repeatable and there were no obvious failures. It should mean having enough confidence in the process, the controls, and the data to know that those…

  • Retention Time Stability: The Foundation of Robust Clinical LC-MS

    In clinical liquid chromatography-mass spectrometry (LC‑MS), sensitivity and specificity often dominate the conversation. But behind every reliable result is a less visible parameter that determines whether workflows scale smoothly or struggle under pressure: retention time stability. As clinical laboratories increasingly rely on LC‑MS for high‑throughput, multi‑analyte testing, retention time stability has become a defining factor…

  • Designing Analytical Methods for Long-Term Audit Readiness

    Audit readiness isn’t a last-minute activity triggered by validation or inspection. It’s established much earlier, at method design, through the scientific understanding, risk-based control, and documentation needed to demonstrate that a method is fit for purpose and capable of performing consistently over time. If those elements aren’t built in from the outset, gaps are likely…

  • Why Chromatography Still Matters in the Age of More Sensitive Mass Spectrometry

    Mass spectrometry (MS) is more powerful than ever. Modern clinical MS systems deliver extraordinary analytical sensitivity, selectivity, and quantitative performance, opening the door to broader test menus with lower detection limits. With capabilities like these, it’s tempting to ask a simple question: Does chromatography still matter as much as it used to? The short answer…

  • Two Truths and a Lie About Solid‑Core Particle Efficiency

    Solid‑core (or superficially porous) particles are the foundation of solid core HPLC columns and have earned a reputation for delivering higher efficiency separations than similarly sized, fully porous particles. Chromatographers see this play out repeatedly across small- and large-molecule applications under a wide range of operating conditions. But why solid‑core particles are more efficient is…

  • FDA October 2025 Draft Guidance Sparks Industry Biosimilars Buzz 

    The FDA’s October 29, 2025 draft guidance has generated significant attention due to the implications for both developers and patients.  By allowing developers to bypass comparative efficacy studies (CES) when advanced analytics are successful substitutes, the draft guidance avoids one of the most expensive steps, estimated to account for 70% of the total biosimilar development…

  • Slalom Chromatography: A High-Speed Path to Nucleic Acid Separation

    Slalom chromatography is no longer just a scientific curiosity, it’s a comeback story. Once sidelined due to limited reproducibility and unclear mechanisms, this technique is now gaining momentum thanks to the rise of nucleic acid therapeutics and advances in UHPLC systems. But its revival wasn’t accidental. It took a year-long deep dive into DNA physics,…

  • Solid-Phase Extraction: From Sample Prep Fundamentals to Best Practices

    Chromatography and mass spectrometry sample preparation is one of the most critical (and underrated) steps in analytical chemistry—ensuring samples are clean and concentrated enough for accurate, reproducible analysis. Shortchanging sample preparation can compromise data accuracy, reduce method robustness, and even cause timely downtime of expensive instrumentation when it matters most. What Are the Challenges in…

  • Improving, Retaining, and Separating Polar Compounds Using Chromatographic Techniques

    Separating and retaining polar compounds are significant challenges in chromatography. Here, we explore the key technical considerations and solutions for effectively handling these compounds, focusing on advanced chromatographic techniques and column technologies.  What Are Polar Compounds?  Polar compounds are essential in biological processes, drug design, and industrial applications due to their ability to interact with…