Catalog Number - 49101-25S

The 49101‑25S Performance Qualification Solutions Set provides a complete replacement suite of NIST‑traceable test solutions for use with HSQ™ and PQ™ HPLC qualification kits, enabling laboratories to maintain ongoing compliance with USP <1058> Analytical Instrument Qualification (AIQ) requirements.

This solution set supports routine performance verification of HPLC systems, ensuring continued accuracy, precision, and system integrity without requiring the purchase of a full new kit.

Key Benefits

• Extend the life and usability of HSQ™ and PQ™ kits

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

• Ensure consistent and traceable qualification results

• Reduce costs by replenishing consumables only

• Enable frequent, routine instrument qualification workflows

Replacement Solution Set Includes

• 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

✅ Fully compatible with HSQ™ and PQ™ qualification kits

Performance Qualification Support

This solution set enables verification of:

• Accuracy

• Precision

• Linearity

• Resolution

• Wavelength accuracy

• Gradient performance

✅ Supports complete HPLC system performance checks aligned with USP <1058>

NIST Traceability & Compliance

• Solutions are NIST traceable for:

  • Reliable measurement accuracy

  • Consistent regulatory compliance

• Designed for audit‑ready documentation and validation workflows

✅ Ideal for regulated laboratories and GMP environments

Shelf Life & Usage

• Solutions supplied with minimum 6 months shelf life upon delivery

• Two‑year expiration from date of manufacture

• Designed for frequent, routine use in qualification programs

✅ Supports scheduled requalification without workflow interruption

Workflow Advantages

Cost‑Effective Replenishment

• Avoids purchasing a full qualification kit

• Maintains long‑term operational efficiency

Continuous Compliance

• Ensures instruments remain in a qualified state between audits

• Supports ongoing AIQ programs

Operational Efficiency

• Enables on‑demand qualification and verification

• Reduces downtime associated with external services

Typical Applications

• Replacement solutions for HSQ™ and PQ™ kits

• HPLC Performance Qualification (PQ)

• USP <1058> compliance programs

• Analytical Instrument Qualification (AIQ)

• Pharmaceutical QC and validation labs

• Routine preventative maintenance workflows

Important Usage Notes

• Designed for use with existing HSQ™ or PQ™ kits

• Follow established SOPs for qualification procedures and documentation

• Store and handle solutions according to recommended conditions

• Ideal for maintaining continuous instrument qualification status