Pharmaceuticals - Technologies for Enhanced LC and SFC Workflow

Comprehensive Analytical Solutions for Pharmaceutical Workflows

Modern pharmaceutical research and production demand robust analytical strategies to ensure drug safety, quality, and regulatory compliance across all stages from early drug discovery through commercial manufacturing and quality control. Advanced workflows combine high-throughput chromatography, sample preparation, impurity detection and identification, chiral separation, data processing, and informatics systems to address these needs efficiently.

Key Technologies and Workflows:

• LC Method Development and Transfer
  • Automated method scouting systems accelerate development by screening hundreds of mobile-phase/column combinations and evaluating separation metrics (resolution, peak count) using software-driven reports.
  • Intelligent Method Transfer Optimization (ACTO) adapts HPLC methods for UHPLC (and vice versa) by calculating flow, gradient delays, and injection parameters, preserving retention times and resolution across platforms.


• Sample Preparation and Purification
  • Preparative LC and LC/MS solutions with fractionation, concentration, and recycle modes handle large-scale purification tasks.
  • Supercritical fluid extraction (SFE) systems automate solid sample pretreatment with CO₂, offering high recovery and low solvent use for fat-soluble vitamins and pesticide residues.


• Impurity Detection, Purity Confirmation, and Identification
  • Photodiode array deconvolution (i-PDeA) isolates coeluting peaks via spectral differentiation, revealing hidden impurities without MS.
  • Intelligent Dynamic Range Extension Calculator (i-DReC) shifts to alternate wavelengths to quantify high-concentration analytes otherwise saturating the detector, extending linear dynamic range.
  • 2D LC/MS trap-free workflows integrate conventional LC with MS/MS in a single run for structural elucidation of impurities in complex mixtures.


• Chiral Separation by SFC
  • Polysaccharide-based chiral selectors in SFC systems deliver rapid, orthogonal separations with minimal solvent consumption.
  • Automated column and modifier switching streamlines condition scouting across dozens of chiral columns and mobile-phase blends.


• Online UHPLC for Dissolution Testing
  • Direct coupling of dissolution apparatus to UHPLC (Nexera FV) automates sampling, dilution, and analysis, generating real-time component concentration and dissolution profiles.
  • Overlap injection modes and advanced autosampler pretreatment reduce cycle times by 30% or more.


• Quantitative Data Processing
  • i-PeakFinder offers fully automated peak integration that detects shoulders, adapts to baseline drift, and maintains reproducibility in batch processing.
  • Multi-chromatogram reporting, in–report data checks, and advanced baseline models ensure accurate quantification across complex runs.


• Data Integrity and IT Solutions
  • LabSolutions CS platform manages instrumentation (LC, GC, MS, spectroscopy) under unified user, audit-trail, and security policies.
  • Report Set functions consolidate batch reports, audit logs, and chromatograms into locked PDF portfolios with digital signatures, ensuring compliance with FDA, MHRA, WHO, and PIC/S requirements.
  • LIMS integration via open interfaces automates sample tracking, instrument scheduling, and data flow between results and enterprise systems.


• Consumables and Columns
  • A broad portfolio of UHPLC, preparative, SFC, and chiral columns matched to Shimadzu systems ensures optimum resolution and reproducibility.
  • Mobile-phase cleaning traps, vial liners, and low-bleed fittings protect analytical performance for trace and high-throughput applications.

These integrated solutions accelerate method development, improve sample throughput, enhance data quality and integrity, and streamline regulatory compliance for pharmaceutical and life-science laboratories.