Ensuring pharma safety with advanced impurity detection

In the pharmaceutical industry, ensuring the safety, efficacy, and quality of drug products is critical, and the detection of impurities plays a key role in this process. Pharmaceutical impurities, such as genotoxic impurities, nitrosamines (NSA), nitrosamines related drug substances (NDSRIs) and extractables and leachables (E&L), pose significant health risks to patients and can lead to product recalls and regulatory issues.

To effectively address these challenges, advanced analytical techniques are crucial. Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) has emerged as the gold standard for impurity profiling, offering unmatched sensitivity and selectivity in detecting trace-level contaminants within complex drug formulations. Among the leading solutions available, the Shimadzu LCMS-TQ RX Series stands out for its superior ability to precisely identify and quantify these harmful impurities, ensuring the highest levels of safety and compliance in pharmaceutical testing.

Shimadzu UFMS Technology: Advancing impurity detection and analysis
Shimadzu offers a wide range of ready-made methods and application notes for analyzing NSA (Nitrosamines), NDSRIs (Nitrosamines-related drug impurities), and genotoxic impurities in APIs and formulations. Additionally, Spinco’s Method Factory enhances efficiency by providing methods for over 200 drugs. This combination of Shimadzu UFMS technology and Spinco’s Method Factory ensures accurate, high-throughput analysis, meeting stringent regulatory standards and advancing drug safety and quality.

Shimadzu LCMS-TQ RX Series: Ultra-Fast and Reliable Performance for Pharmaceutical Impurity Detection
The Shimadzu LCMS-TQ RX Series is a state-of-the-art triple quadrupole mass spectrometer, offering unmatched performance for impurity detection in pharmaceutical applications. Key features include:

• IonDrive™ Technology: Provides exceptional sensitivity with fast scan speeds of 30,000 scans per second, enabling rapid, reproducible analysis of trace-level contaminants such as genotoxic impurities and nitrosamines.
• Ultra-Fast Polarity Switching (5 ms): Allows seamless analysis of a wide range of compounds without sacrificing sensitivity or data quality, enhancing throughput for high-demand pharmaceutical testing.
• Enhanced Ion Guide & Collision Cell Technologies: Focuses the ion beam for improved data quality and accuracy, essential for precise impurity quantification in complex formulations.
• Heated ESI Probe & CoreSpray Technology: Delivers superior ionization, ensuring accurate and reproducible results even for challenging impurities.
• High Resolution & Robust Quantitation: Ensures excellent selectivity and compliance with stringent regulatory standards, making it ideal for high-throughput pharmaceutical testing.