Streamlining Impurity Management Using LabSolutions Detect

User Benefits

- LabSolutions Detect automates impurity peak detection and identification, improving the efficiency of impurity management. - By coupling a single quadrupole mass spectrometer (LCMS-2050), mass information can be acquired as qualitative information for impurity peaks.

Introduction

In the pharmaceutical development process, the qualitative and quantitative analysis and appropriate management of impurities are essential to ensure product safety. For example, during active pharmaceutical ingredient (API) synthesis, various impurities are generated throughout multi-step synthetic routes from starting materials to the final API. Accordingly, the ICH guidelines define threshold levels at which impurity identification is required, and such impurities must be controlled within acceptable limits. In addition, stability testing of pharmaceuticals is conducted to evaluate time-dependent changes under various exposure conditions in order to ensure product safety and determine shelf life. Degradation products generated under these exposure conditions must also be appropriately managed to monitor such changes over time. However, when multiple impurities and degradation products are managed manually, tasks such as peak detection and peak identification carry the risk of missed detections and human error. LabSolutions Detect, an anomaly peak detection support software, automates peak detection and peak identification for arbitrary peaks, including impurities and degradation products. In this article, case examples are presented in which peak detection and peak tracking were automated for multiple model samples assuming different impurity profiles, thereby streamlining impurity management. Furthermore, the combined use of a single quadrupole mass spectrometer (LCMS-2050) demonstrates that mass information can be acquired as qualitative information for each peak.

June 2, 2026 GMT