Grace Vydac C18 Monomeric 120Å HPLC Column

Overview

The Grace Vydac C18 Monomeric 120Å HPLC Column is a high-performance reversed-phase analytical column engineered for robust separation of small- to medium-molecular-weight compounds under standard and demanding gradient conditions. Built upon a monomeric C18 bonding architecture—distinct from polymeric or hybrid phases—the column delivers exceptional batch-to-batch reproducibility, minimized silanol activity, and enhanced stability across pH 2–8. Its 120 Å pore size provides optimal surface area and diffusion kinetics for analytes with molecular weights up to ~2,000 Da, making it particularly suitable for pharmaceutical impurity profiling, peptide mapping, natural product isolation, and QC testing in regulated environments. The silica support is fully endcapped, reducing secondary interactions and improving peak symmetry for basic compounds. This refurbished unit has undergone full functional validation—including backpressure verification, retention time consistency checks, and efficiency assessment via USP tailing factor (Tf ≤ 1.5) and plate count (N ≥ 8,000/m) on standard test mixtures—and is certified for immediate integration into ISO/IEC 17025-compliant laboratories.

Key Features

• Monomeric C18 ligand density (~3.5 µmol/m²) ensures predictable retention and low hydrophobic collapse risk during aqueous-rich mobile phase conditions
• 120 Å pore diameter optimized for balanced resolution and mass transfer efficiency in small-molecule separations
• High-purity, low-metal-content silica base (Fe < 10 ppm, Al < 5 ppm) minimizes catalytic degradation of sensitive analytes
• Consistent lot-to-lot performance validated per ASTM D7819-19 (Standard Practice for HPLC Column Performance Testing)
• Refurbished and requalified per internal SOP-CHROM-04: includes leak testing, pressure cycling (0–400 bar × 5 cycles), and system suitability confirmation using caffeine/acetophenone/uracil test mixture
• Compatible with all major HPLC and UHPLC systems operating at ≤ 600 bar, including Agilent 1260/1290, Waters Acquity/UPLC, and Shimadzu Nexera series

Sample Compatibility & Compliance

This column supports a broad range of sample matrices, including aqueous buffers (e.g., ammonium formate/acetonitrile), low-pH acidic mobile phases (0.1% TFA), and moderate organic modifiers (up to 95% acetonitrile or methanol). It is routinely deployed in applications requiring adherence to pharmacopeial standards—including USP , EP 2.2.46, and JP 6.07—as well as ICH Q2(R2)-aligned method validation protocols. All refurbishment documentation—including pre- and post-validation chromatograms, pressure logs, and column history traceability—is retained for GLP/GMP audit readiness. The column does not require special handling beyond standard HPLC column storage guidelines (stored in ≥ 80% organic solvent, capped, at room temperature).

Software & Data Management

While the column itself is hardware-only, its performance data integrates seamlessly with industry-standard chromatography data systems (CDS), including Empower 3, Chromeleon 7.3+, and OpenLab CDS. System suitability reports generated during qualification include automated calculation of resolution (Rs), selectivity (α), asymmetry (As), and theoretical plates (N)—all compliant with FDA 21 CFR Part 11 requirements when executed within validated CDS environments. Raw data files (.arw, .cdf, .u2) are fully exportable for third-party review or statistical process control (SPC) analysis in JMP or Minitab.

Applications

• Pharmaceutical QC release testing of APIs and finished dosage forms (e.g., assay, related substances per ICH Q5A/Q6A)
• Stability-indicating method development for forced degradation studies (acid/base/oxidative/thermal)
• Environmental analysis of pesticides and herbicides per EPA Method 8330B
• Food safety testing: mycotoxin quantification (aflatoxins, ochratoxin A) and vitamin profiling
• Academic and contract research labs performing method transfer between legacy and modern LC platforms

FAQ

Is this column eligible for inclusion in an FDA-submitted analytical procedure?
Yes—provided full qualification records (including system suitability, column history, and revalidation data) are archived and accessible during inspection.
Can this column be used with 100% aqueous mobile phases?
It is not recommended for prolonged use in 100% water due to potential phase dewetting; a minimum of 5% organic modifier is advised for column equilibration and storage.
What documentation accompanies the column upon shipment?
A Certificate of Refurbishment, pre- and post-validation chromatograms, pressure test log, and full traceability report (lot number, prior usage history, cleaning protocol) are included digitally and in hard copy.
Does the 6-month warranty cover performance drift during routine use?
Yes—the warranty covers failure to meet original specifications (e.g., >20% drop in plate count, Tf > 2.0, or sudden pressure increase >30% above baseline) under documented, manufacturer-recommended operating conditions.