Catalog Number - 49101-07

The 49101‑07 HSQ™ Complete Kit provides a comprehensive, high‑speed solution for HPLC performance qualification (PQ), enabling laboratories to verify instrument accuracy, precision, and system suitability in‑house without relying on external service providers.

Designed to support USP <1058> Analytical Instrument Qualification (AIQ) requirements, this kit enables both holistic and modular instrument testing—allowing users to maintain systems in a continuously qualified state with minimal disruption to workflow.

Key Benefits

• Perform complete HPLC qualification in less than half a workday

• Enables preventative maintenance with immediate instrument uptime

• Eliminates delays associated with vendor scheduling and service visits

• Supports compliance with USP <1058> requirements for maintaining instrument qualification

• Suitable for routine requalification, troubleshooting, and validation workflows

Complete HSQ™ 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 – 75 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

Performance Qualification Capabilities

This kit supports qualification of:

• Precision

• Accuracy

• Linearity

• Resolution

• Wavelength accuracy

• Gradient performance

✅ Enables full system verification compliant with USP <1058> guidelines

Throughput & Shelf Life

• Approximately 25 full instrument qualifications per kit (with proper use)

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

• Two‑year expiration from date of manufacture

✅ Designed for frequent, routine qualification workflows

Workflow Advantages

Fast In‑House Qualification

• Complete PQ testing in less than half a day

• Reduces instrument downtime

Regulatory Confidence

• Supports USP <1058> compliance

• Enables audit‑ready qualification records

Cost & Time Savings

• Eliminates external service dependency

• Reduces long‑term qualification costs

Typical Applications

• HPLC Performance Qualification (PQ)

• USP <1058> compliance programs

• Analytical Instrument Qualification (AIQ)

• Pharmaceutical QC laboratories

• Contract testing and regulated environments

• Preventative maintenance workflows

Important Usage Notes

• Designed for routine in‑house instrument qualification

• Follow provided SOP templates and instructions for compliance documentation

• Ideal for maintaining instruments in a qualified state between audits

• Store and use solutions per recommended guidelines to preserve accuracy