Hypersil GOLD C18 Reversed-Phase HPLC Column (5 µm, 4.6 × 250 mm)

Overview

The Hypersil GOLD C18 Reversed-Phase HPLC Column is an engineered chromatographic separation tool designed for high-fidelity, reproducible retention and peak shape across diverse small-molecule applications. Built on ultra-pure, low-metal-content silica with proprietary bonding and endcapping chemistry, this column delivers robust performance under demanding analytical conditions—including low-pH acidic eluents, high-pH basic buffers, and fully aqueous mobile phases. Its underlying mechanism relies on hydrophobic interactions between analytes and the densely grafted C18 ligand layer, while minimized silanol activity ensures minimal secondary interactions—particularly critical for basic, ionizable compounds prone to tailing on conventional silica-based columns. As a result, it supports compliance-driven workflows in pharmaceutical QC, environmental residue analysis, food safety testing, and clinical research laboratories where peak symmetry, resolution, and quantitative accuracy are non-negotiable.

Key Features

• Superior Peak Symmetry: Achieves near-Gaussian peak profiles for basic compounds (e.g., amines, alkaloids), reducing tailing and maximizing signal-to-noise ratio—essential for accurate integration and trace-level quantitation per ICH Q2(R2) and USP <621> guidelines.
• Extended pH Operational Range: Demonstrated stability over pH 1.8–10.6 under accelerated testing protocols (≥1500 injections at pH 1.8; ≥650 injections at pH 10.6), enabling method development flexibility beyond standard silica limitations without compromising column lifetime.
• Enhanced Resolution & Peak Capacity: Optimized surface coverage and steric shielding yield sharper, more resolved peaks—particularly beneficial in complex matrix separations such as peptide mapping or multi-residue pesticide screening.
• 100% Aqueous Mobile Phase Compatibility: Resists phase collapse through advanced bonding density and ligand orientation control, ensuring consistent retention time and efficiency during gradient elution starting from 100% water—critical for polar compound retention and method ruggedness.
• Batch-to-Batch Reproducibility: Manufactured under ISO 9001-certified processes with rigorous QC testing (retention time, asymmetry factor, plate count), supporting GLP/GMP-compliant documentation requirements.

Sample Compatibility & Compliance

The Hypersil GOLD C18 column is validated for use with standard reversed-phase HPLC systems operating under isocratic or gradient conditions. It accommodates a broad range of analytes—including acids, bases, neutrals, and zwitterions—with particular efficacy for protonatable nitrogen-containing molecules (e.g., β-blockers, antihistamines, antibiotics). Its high-purity silica substrate meets ASTM D7883 and USP Class I specifications for residual metal content (<10 ppm Fe, Al, Ni), minimizing catalytic degradation of labile compounds. Column hardware complies with ANSI/SLAS standard dimensions for universal compatibility with autosamplers, column ovens, and detector flow cells. While not pre-certified for FDA 21 CFR Part 11 environments, its performance consistency supports audit-ready data integrity when integrated into validated software platforms.

Software & Data Management

No embedded firmware or proprietary software is required—the column operates transparently within any vendor-neutral HPLC data system (e.g., Waters Empower, Thermo Chromeleon, Agilent OpenLab CDS). Retention time stability, peak asymmetry (As), and theoretical plate count (N) are directly reportable via standard system suitability protocols. For regulatory submissions, column lot-specific test chromatograms and QC certificates—including batch-specific k′, α, and As values—are available upon request to support method transfer and long-term trending per ICH Q5C and Q5D recommendations.

Applications

• Pharmaceutical impurity profiling and assay validation per ICH Q3B and USP <1058>
• Residual solvent analysis in APIs using headspace-GC/HPLC hybrid workflows
• Multi-class pesticide residue determination in fruits, vegetables, and cereals (EN 15662:2018)
• Endogenous metabolite quantification in plasma and urine (LC-MS/MS sample prep support)
• Stability-indicating methods for biodegradable polymers and excipient interaction studies

FAQ

What is the recommended maximum operating pressure for this column?
The column is rated for continuous operation up to 400 bar (5800 psi) at ambient temperature when used with standard stainless-steel hardware.
Can this column be used with LC-MS systems?
Yes—its low bleed characteristics and compatibility with volatile mobile phases (e.g., 0.1% formic acid in water/acetonitrile) make it suitable for electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI) interfaces.
Is column regeneration possible after exposure to high-pH mobile phases?
Regeneration is not routinely recommended; however, gradual equilibration with intermediate pH solvents (e.g., pH 5–7 buffer) prior to storage mitigates irreversible siloxane bond hydrolysis.
Does Elite provide column care documentation aligned with ISO/IEC 17025 requirements?
Yes—certificates of analysis, installation qualification (IQ) templates, and preventive maintenance logs are supplied with each batch shipment upon request.
How does Hypersil GOLD compare to legacy Hypersil ODS columns in method transfer scenarios?
Retention times typically shift by ≤5% due to higher carbon load and improved surface homogeneity; re-optimization of gradient slope or organic modifier concentration is generally sufficient for seamless transfer.