PQ Kit, Complete. 150 mm HPLC column, test solutions, accessories & software for performance qualification. Chemical Solutions brand. 1 EA.

Additional Info:

The 49101‑10 PQ Kit™ Complete provides a fully integrated solution for HPLC performance qualification (PQ), enabling laboratories to perform in‑house instrument validation and maintain compliance with USP <1058> Analytical Instrument Qualification (AIQ) guidelines.

Designed for holistic and modular qualification workflows, this kit allows laboratories to verify system accuracy, precision, and overall performance while maintaining continuous instrument uptime—without reliance on external service providers.


The 49101‑10 PQ Kit™ Complete provides a fully integrated solution for HPLC performance qualification (PQ), enabling laboratories to perform in‑house instrument validation and maintain compliance with USP <1058> Analytical Instrument Qualification (AIQ) guidelines.

Designed for holistic and modular qualification workflows, this kit allows laboratories to verify system accuracy, precision, and overall performance while maintaining continuous instrument uptime—without reliance on external service providers.


Key Benefits

  • Perform complete HPLC performance qualification (PQ) in‑house

  • Maintain instruments in a qualified state per USP <1058>

  • Eliminate delays from third‑party service scheduling

  • Enable preventative maintenance with minimal downtime

  • Support audit‑ready compliance and documentation


Complete PQ Kit™ Contents

  • 6 Linearity Solutions – 30 mL each (L2 and L3 supplied as 60 mL)

  • 1 Resolution Test Mixture – 30 mL

  • 1 Wavelength Calibration Solution (Holmium Oxide) – 4 mL

  • 1 Gradient Visualization Solution – 30 mL

  • 1 Cogent Certified HPLC Test Column – 150 mm × 4.6 mm

  • 1 Software Template – Excel‑based with operator‑defined criteria

  • 1 Accessory Kit – Flow cell filling pump components

  • 1 Quick Start Instruction Guide


150 mm Column – Increased Resolution for Qualification Accuracy

  • Provides higher resolving power than 75 mm HSQ kits

  • Improves accuracy in resolution and system suitability testing

  • Enhances detection of subtle performance deviations

  • Ideal for full PQ validation and regulatory‑focused workflows

✅ Preferred when maximum qualification accuracy and system verification are required


Performance Qualification Capabilities

This kit supports verification of:

  • Precision

  • Accuracy

  • Linearity

  • Resolution

  • Wavelength accuracy

  • Gradient performance

✅ Enables complete system qualification aligned with USP <1058> requirements


Throughput & Shelf Life

  • Approximately 25 full instrument qualifications per kit

  • Solutions supplied with minimum 6‑month shelf life upon delivery

  • Two‑year expiration from date of manufacture

✅ Optimized for routine qualification and ongoing compliance programs


Workflow Advantages

Comprehensive PQ Testing

  • Designed for full instrument validation workflows

  • Ideal for regulated and audit‑intensive environments

Regulatory Confidence

  • Supports USP <1058> compliance and AIQ protocols

  • Generates consistent, reproducible qualification data

Time & Cost Efficiency

  • Eliminates dependence on external service vendors

  • Reduces downtime and long‑term validation costs


Typical Applications

  • HPLC Performance Qualification (PQ)

  • USP <1058> compliance programs

  • Analytical Instrument Qualification (AIQ)

  • Pharmaceutical QC and validation laboratories

  • Contract testing and regulated environments

  • Routine preventive maintenance programs


Important Usage Notes

  • Designed for in‑house HPLC qualification and compliance workflows

  • Follow provided SOP templates and documentation procedures

  • Ideal for maintaining instruments in a continuous qualified state

  • Store and use solutions according to recommended handling guidelines

  • Perform complete HPLC performance qualification (PQ) in‑house

  • Maintain instruments in a qualified state per USP <1058>

  • Eliminate delays from third‑party service scheduling

  • Enable preventative maintenance with minimal downtime

  • Support audit‑ready compliance and documentation


Complete PQ Kit™ Contents

  • 6 Linearity Solutions – 30 mL each (L2 and L3 supplied as 60 mL)

  • 1 Resolution Test Mixture – 30 mL

  • 1 Wavelength Calibration Solution (Holmium Oxide) – 4 mL

  • 1 Gradient Visualization Solution – 30 mL

  • 1 Cogent Certified HPLC Test Column – 150 mm × 4.6 mm

  • 1 Software Template – Excel‑based with operator‑defined criteria

  • 1 Accessory Kit – Flow cell filling pump components

  • 1 Quick Start Instruction Guide


150 mm Column – Increased Resolution for Qualification Accuracy

  • Provides higher resolving power than 75 mm HSQ kits

  • Improves accuracy in resolution and system suitability testing

  • Enhances detection of subtle performance deviations

  • Ideal for full PQ validation and regulatory‑focused workflows

✅ Preferred when maximum qualification accuracy and system verification are required


Performance Qualification Capabilities

This kit supports verification of:

  • Precision

  • Accuracy

  • Linearity

  • Resolution

  • Wavelength accuracy

  • Gradient performance

✅ Enables complete system qualification aligned with USP <1058> requirements


Throughput & Shelf Life

  • Approximately 25 full instrument qualifications per kit

  • Solutions supplied with minimum 6‑month shelf life upon delivery

  • Two‑year expiration from date of manufacture

✅ Optimized for routine qualification and ongoing compliance programs


Workflow Advantages

Comprehensive PQ Testing

  • Designed for full instrument validation workflows

  • Ideal for regulated and audit‑intensive environments

Regulatory Confidence

  • Supports USP <1058> compliance and AIQ protocols

  • Generates consistent, reproducible qualification data

Time & Cost Efficiency

  • Eliminates dependence on external service vendors

  • Reduces downtime and long‑term validation costs


Typical Applications

  • HPLC Performance Qualification (PQ)

  • USP <1058> compliance programs

  • Analytical Instrument Qualification (AIQ)

  • Pharmaceutical QC and validation laboratories

  • Contract testing and regulated environments

  • Routine preventive maintenance programs


Important Usage Notes

  • Designed for in‑house HPLC qualification and compliance workflows

  • Follow provided SOP templates and documentation procedures

  • Ideal for maintaining instruments in a continuous qualified state

  • Store and use solutions according to recommended handling guidelines

 

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