Shimadzu Journal vol.8 Issue1

Význam tématu

Pharmaceutical analysis must continuously evolve to address emerging public health challenges (e.g., COVID-19), detect genotoxic impurities (e.g., NDMA in ranitidine and metformin), and comply with global regulations on elemental contaminants. High-performance, robust, and automated analytical technologies are essential to safeguard drug quality and patient safety.

Cíle a přehled studie / článku

This issue compiles reports on:

• A cross-industry collaboration (Enabling Technologies Consortium) leading to a new mid-scale preparative SFC instrument.
• Method development for hydroxychloroquine sulfate and impurities by EP10.0 and USP43 HPLC/UHPLC.
• LC-MS/MS and HRMS protocols for quantifying NDMA in ranitidine.
• LC-MS/MS, GC-MS/MS, and GC-MS approaches for NDMA in metformin.
• Implementation of ICH Q3D elemental impurity guidelines using ICP-MS, ICP-OES, and EDX.
• Additional application notes and highlights of Shimadzu’s latest products and global initiatives.

Použitá metodika a instrumentace

Key techniques and instruments:

• Prototype preparative SFC system with Shimadzu pumps, back-pressure regulator, PrepSolution software, and novel gas–liquid separator.
• UHPLC (LC-30A) and HPLC (LC-2040C 3D) for hydroxychloroquine assays.
• Shimadzu LCMS-8050 QqQ and LCMS-9030 Q-TOF MS, plus GCMS-TQ8050 NX and GCMS-QP2020 NX for NDMA quantitation.
• ICPMS-2030, ICPE-9820, and EDX-RF instruments for multi-element impurity screening.
• Supporting technologies: microflow LC-MS/MS, MALDI-DIT, microchip electrophoresis, and flow imaging particle analysis.
• New product launches: LCMS-8060NX, UV-i Selection spectrophotometers, Shim-pack Bio HIC columns.

Hlavní výsledky a diskuse

• The new SFC instrument met all performance criteria for resolution, robustness, and user-friendly operation, enabling efficient chiral and impurity purifications.
• Hydroxychloroquine assays achieved EP and USP requirements: resolution >3, RSD% <0.1–0.6%, assay content ca. 99.99%.
• Regulatory levels of NDMA were quantified at <1 ng/mL in ranitidine and <5 ng/g in metformin with high sensitivity (S/N>10) and linearity (r>0.999).
• Multi-element impurities in drug products were successfully measured in compliance with ICH Q3D using ICP-MS, ICP-OES, and EDX without excessive sample pretreatment.
• Case studies highlighted the impact of analytical intelligence and AI, medical cannabis research collaborations, and immunotherapy QC partnerships.

Přínosy a praktické využití metody

• Automated, AI-driven workflows improve productivity, reduce downtime, and minimize operator variability.
• Comprehensive compliance solutions support elemental and genotoxic impurity control, ensuring patient safety.
• Versatile preparative and analytical platforms accelerate drug discovery, development, and quality control processes.
• Expanded capabilities address emerging areas such as medical cannabis, cancer immunotherapy, and biosimilar characterization.

Budoucí trendy a možnosti využití

Looking ahead, the integration of AI-enabled instrument control, remote monitoring, and data analytics will drive the next generation of laboratory efficiency. Portable MS devices, high-throughput microflow and MALDI approaches, and M2M connectivity will further empower personalized medicine and global collaborative research.

Závěr

Shimadzu’s collaborative developments and comprehensive analytical solutions demonstrate the evolving landscape of pharmaceutical analysis. By delivering sensitive, robust, and automated technologies, Shimadzu supports regulatory compliance, accelerates development timelines, and helps ensure the safety and efficacy of therapeutics.

Reference

Key references:

• Welch CJ, et al. Org. Process Res. Dev. 2020,24,1271–1280.
• Shimadzu Application Notes: LC-199; AN C145A; JPB416006; APB419001.
• FDA, USP <232>/<233>, Ph. Eur. Chapter 2.4.20, ICH Q3D guidelines.
• Analytical techniques for NDMA: National Institutes for Food and Drug Control; Health Sciences Authority of Singapore reports.