Catalog Number - 49101-50C

The 49101‑50C Performance Qualification HPLC Column is a certified replacement column for the PQ™ (Performance Qualification) Kit, specifically selected and validated to ensure high‑precision, reproducible performance for HPLC instrument qualification.

Each column is laboratory tested and certified, ensuring consistent system performance for accuracy, precision, and resolution verification, supporting compliance with USP <1058> Analytical Instrument Qualification (AIQ) requirements.

150 mm Column – Maximum Resolution for PQ Validation

• Provides greater resolving power than HSQ (75 mm) columns

• Enables higher sensitivity to system performance deviations

• Improves accuracy in resolution and system suitability evaluation

• Ideal for full PQ validation and regulatory‑focused workflows

✅ Preferred when maximum qualification accuracy and validation depth are required

4.6 mm ID – Standard Analytical Platform

• Compatible with standard HPLC systems

• Ensures reproducible qualification test conditions

• Maintains method consistency across qualification cycles

Typical Flow Rate Range

• ~0.8–1.5 mL/min

✅ Suitable for standard analytical systems without special requirements

5 µm Particle – Balanced Qualification Performance

• Provides reliable efficiency and reproducibility

• Matches common analytical HPLC configurations

• Ensures stable, repeatable system suitability testing

✅ Ideal for routine PQ workflows and compliance testing

Certified Performance for Compliance

• Includes Certificate of Performance

• Pre‑validated to meet qualification‑specific criteria

• Ensures consistent, audit‑ready performance data

✅ Critical for regulatory documentation and compliance audits

Designed for PQ™ Kit Compatibility

• Direct replacement for the original PQ™ kit column

• Maintains validated system configuration

• Ensures continuity of SOP‑based qualification procedures

Workflow Advantages

High‑Confidence Validation

• Optimized for full PQ workflows and regulatory environments

• Enables precise measurement of instrument performance

Minimal Downtime

• Replace only the column without disrupting qualification programs

• Maintain continuous instrument readiness

Cost‑Effective Maintenance

• Extends lifecycle of PQ™ kits

• Reduces need for complete kit replacement

Typical Applications

• Replacement for PQ™ qualification columns

• HPLC Performance Qualification (PQ)

• Analytical Instrument Qualification (AIQ)

• USP <1058> compliance workflows

• Pharmaceutical QC and validation labs

• Routine system verification and maintenance

Important Usage Notes

• Designed specifically for use with PQ™ qualification kits

• Use with validated solutions and SOPs for accurate system qualification

• Retain certificate for audit and compliance documentation

• Ensure system setup matches validated test parameters