Aotsaisiens Kromasil™-Based HPLC Columns (C18, C8, NH₂, Silica) – Various Dimensions & Particle Sizes

Overview

Aotsaisiens offers a comprehensive portfolio of high-performance liquid chromatography (HPLC) columns engineered for analytical precision, method robustness, and long-term column lifetime. These columns utilize Kromasil™ spherical silica—manufactured by Eka Nobel (now part of AkzoNobel)—as the base stationary phase material. Kromasil™ silica is distinguished by its narrow particle size distribution (dp₉₀/dp₁₀ < 1.7, measured via Coulter Counter), exceptional batch-to-batch consistency, and ultra-low metal impurity content (<10 ppm each for Na, Al, Fe, per atomic absorption spectroscopy). The resulting bonded phases—including fully end-capped C18, C8, amino (NH₂), and bare silica—are designed for compatibility with reversed-phase, normal-phase, and mixed-mode separations across diverse application domains including pharmaceutical QC, environmental residue analysis, food safety testing, and fine chemical synthesis monitoring.

Key Features

• High-purity, spherical silica substrate with uniform 100 Å pore diameter and 340 m²/g BET surface area—optimized for efficient mass transfer and high resolution.
• Narrow particle size distribution ensures reproducible packing density and minimal backpressure variation across batches.
• Chemically stable under extended gradient elution conditions between pH 1.5 and 9.5—enabling reliable separation of acidic, basic, and zwitterionic analytes without column degradation.
• Mechanically robust construction supports operation at up to 700 bar (10,000 psi), making these columns suitable for both conventional HPLC and UHPLC-compatible systems when used with appropriate instrumentation.
• Multiple particle sizes (5 µm standard; 7 µm for C18; 10 µm for preparative screening) and column dimensions (150 × 4.6 mm, 200 × 4.6 mm, 250 × 4.6 mm) allow method scalability from analytical development to routine quality control.

Sample Compatibility & Compliance

These columns are validated for use in regulated environments requiring adherence to pharmacopeial standards (USP L1, L7, L8, L10 classifications), ISO/IEC 17025-accredited laboratories, and GLP-compliant studies. The low metal content minimizes catalytic degradation of labile compounds (e.g., phosphates, catechols), while full end-capping of C18 phases reduces silanol activity—critical for peak symmetry of basic drugs. Columns meet ASTM D7260 requirements for silica-based HPLC column characterization and are compatible with mobile phases containing aqueous buffers (e.g., phosphate, acetate), organic modifiers (acetonitrile, methanol), and ion-pairing reagents. All lots undergo rigorous QC testing for plate count (≥8,000 plates/m for 150 mm × 4.6 mm, 5 µm C18), asymmetry factor (0.9–1.3 for caffeine), and pressure stability over 500 injections.

Software & Data Management

While physically column-based, integration into modern chromatographic data systems (CDS) such as Waters Empower, Thermo Chromeleon, Agilent OpenLab CDS, and Shimadzu LabSolutions is seamless. Column metadata—including lot number, manufacturing date, test chromatograms, and certificate of analysis (CoA)—is provided digitally in PDF format compliant with 21 CFR Part 11 requirements for electronic records. Each CoA includes retention time reproducibility data (RSD < 0.3% over 10 injections), backpressure profile, and system suitability results against USP reference standards. Traceability is maintained through unique serialization and QR-coded labeling for audit-ready inventory management.

Applications

• Pharmaceutical analysis: Assay and impurity profiling of APIs per ICH Q2(R2); dissolution testing; stability-indicating methods for biologics and small molecules.
• Environmental monitoring: Multi-residue pesticide screening (EPA Method 531.1, 8081B), PAHs, PCBs, and emerging contaminants (PFAS) in water and soil extracts.
• Food & beverage: Mycotoxin quantification (aflatoxins, ochratoxin A), vitamin analysis (B-complex, D), and adulterant detection (melamine, Sudan dyes).
• Chemical R&D: Chiral separation support (when used with chiral derivatization or as part of SFC mobile phase systems); purification monitoring in SMB and simulated moving bed applications.
• Academic & clinical research: Metabolomics profiling (polar/non-polar metabolite coverage using NH₂ and C18 dual-column strategies); peptide mapping under denaturing conditions.

FAQ

Are these columns manufactured in China or imported directly from Sweden?

The Kromasil™ silica raw material is produced in Sweden by AkzoNobel; final column packing, testing, and quality certification are performed in Tianjin, China, under Aotsaisiens’ ISO 9001-certified production facility.

What is the recommended storage solvent for long-term preservation?

Store columns in ≥80% organic solvent (e.g., acetonitrile or methanol) at room temperature; avoid prolonged exposure to pure water or high-pH mobile phases (>9.5) without proper equilibration protocols.

Do you provide column regeneration protocols for performance recovery?

Yes—detailed regeneration workflows (including solvent gradients, flow rate ramping, and temperature conditioning) are included in the technical manual and supported by application scientists for method-specific troubleshooting.

Is method transfer validation data available for regulatory submissions?

Upon request, Aotsaisiens supplies full method transfer reports aligned with ICH Q5C and Q2(R2), including intermediate precision, ruggedness, and forced degradation studies conducted on qualified reference columns.

Can these columns be used in UHPLC systems operating above 600 bar?

The 5 µm versions are rated for ≤600 bar; the 7 µm and 10 µm variants are intended for HPLC systems (≤400 bar). For true UHPLC applications, consult the Aotsaisiens Ultra Series line featuring sub-2 µm particles and reinforced stainless-steel hardware.