ZHONGKEHUIFEN HPLC Column Series

Overview

The ZHONGKEHUIFEN HPLC Column Series comprises a comprehensive portfolio of high-performance liquid chromatography (HPLC) and ultra-high-performance liquid chromatography (UHPLC) columns engineered for robust separation efficiency, batch-to-batch reproducibility, and extended column lifetime. These columns operate on the fundamental principle of partition chromatography—where analytes are differentially distributed between a mobile phase (liquid solvent system) and a stationary phase (chemically bonded silica or polymer support)—enabling precise retention time control, peak symmetry, and resolution of complex mixtures across pharmaceutical, environmental, food safety, and academic research applications. Each column undergoes rigorous quality control per ISO 9001–certified manufacturing protocols, including pressure testing, backpressure validation, and retention time consistency verification using standardized test mixtures (e.g., USP L1, L3, L7, and L10 reference standards).

Key Features

• Wide range of stationary phases: C18, C8, phenyl-hexyl, pentafluorophenyl (PFP), amino (NH₂), cyano (CN), and HILIC chemistries—each optimized for specific selectivity profiles and pH stability (pH 1.5–10.5 for hybrid silica-based variants).
• High-purity, spherical, fully porous or superficially porous (core-shell) silica particles with nominal diameters of 1.7 µm, 2.6 µm, 3 µm, 5 µm, and 10 µm—compatible with both conventional HPLC and UHPLC systems.
• Endcapped and double-endcapped options available to minimize silanol activity and improve peak shape for basic compounds.
• Consistent packing density and column-to-column reproducibility (RSD < 2% for k’ and α values across same-batch lots).
• Mechanically stable stainless-steel or PEEK-lined hardware with standard 1/4″-28 UNF or M7 × 0.5 inlet/outlet threads; compatible with Waters, Agilent, Shimadzu, Thermo Fisher, and other major LC platform interfaces.

Sample Compatibility & Compliance

The ZHONGKEHUIFEN HPLC Column Series supports analysis of small-molecule pharmaceuticals, peptides, organic acids, polar metabolites, pesticides, PAHs, and ionic species under isocratic or gradient elution conditions. Columns are validated for compatibility with common mobile phases—including aqueous buffers (e.g., ammonium formate, phosphate, acetate), organic modifiers (acetonitrile, methanol, isopropanol), and additives (TFA, TEA, HFBA)—within recommended pressure and pH limits. All columns comply with ICH Q5A/Q5B guidelines for column qualification in regulated environments and meet baseline requirements for GLP and GMP-compliant laboratories. Documentation includes Certificate of Analysis (CoA), column performance report, and lot-specific chromatograms traceable to NIST-traceable reference standards.

Software & Data Management

While HPLC columns are passive consumables and do not incorporate embedded firmware or software, ZHONGKEHUIFEN provides digital column management support through its ColumnLog™ companion tool—a web-accessible database enabling users to register serial numbers, track usage history (injection count, solvent exposure, maintenance logs), and generate audit-ready reports aligned with FDA 21 CFR Part 11 requirements for electronic records. Integration with major chromatography data systems (CDS) such as Empower, Chromeleon, and OpenLab is achieved via standardized metadata fields (e.g., column ID, dimensions, phase chemistry, manufacturing date), facilitating automated method transfer and instrument configuration validation.

Applications

• Pharmaceutical QC/QA: Assay, related substances, residual solvents, and stability-indicating methods per USP , EP 2.2.46, and JP 6.03.
• Biopharmaceutical characterization: Peptide mapping, monoclonal antibody subunit analysis, and glycan profiling using specialized C4 and wide-pore C18 variants.
• Environmental monitoring: Multi-residue pesticide screening in soil/water extracts and PFAS analysis using PFP-phase columns.
• Clinical and forensic toxicology: Quantitative determination of drugs of abuse, antidepressants, and antipsychotics in plasma/urine matrices.
• Food & beverage testing: Mycotoxin detection (aflatoxins, ochratoxin A), vitamin quantification, and adulterant screening (e.g., melamine, Sudan dyes).

FAQ

Are these columns suitable for UHPLC systems operating above 1000 bar?
Yes—core-shell and sub-2-µm fully porous variants are rated for maximum operating pressures up to 1300 bar and feature low longitudinal diffusion coefficients for optimal efficiency at high linear velocities.
Do you provide column regeneration protocols?
Standard cleaning procedures (e.g., gradient flushing with water/acetonitrile/methanol/TFA combinations) are included in the User Guide; custom regeneration sequences for heavily fouled columns can be requested via technical support.
Is method transfer support available?
ZHONGKEHUIFEN offers free column equivalency assessment services—including retention time prediction, selectivity comparison, and system suitability testing—using proprietary retention modeling tools calibrated against >200 reference methods.
Can columns be re-packed or refurbished?
No—columns are single-use consumables designed for defined lifetime; re-packing compromises packing homogeneity and void formation, violating ISO/IEC 17025 and regulatory validation expectations.
What documentation accompanies each column shipment?
Each box includes a printed CoA, lot-specific performance chromatogram, packing slip, and QR-coded access to digital version of the Safety Data Sheet (SDS) and Regulatory Compliance Summary.