HPLC Qualification Kits for USP <1058>, PQ™ & HSQ™

DIY HPLC qualification kits for Performance Qualification (PQ™), High-Speed Qualification (HSQ™), and Health-of-the-System (HoX) testing. Designed for laboratories performing in-house HPLC qualification using NIST-traceable standards to support USP <1058> programs, instrument performance verification, and audit readiness.

Select Your Qualification System

• PQ™ Qualification Kits for traditional qualification workflows using a 150 × 4.6 mm test column.

• HSQ™ Qualification Kits for faster qualification using a shorter high-efficiency test column while maintaining equivalent qualification results.

What Are DIY HPLC Qualification Kits?

DIY HPLC qualification kits provide laboratories with certified materials, validated procedures, qualification columns, and documentation tools used to verify HPLC instrument performance without relying on external service providers.

These kits are commonly used in pharmaceutical, biopharmaceutical, quality control, research, and regulated laboratory environments.

Which Qualification Kit Do I Need?

Choose PQ™ Qualification Kits When:

• Following traditional qualification protocols

• Extended run times are acceptable

• Replicating legacy qualification procedures

• Standard qualification workflows are preferred

Choose HSQ™ Qualification Kits When:

• Qualification time must be minimized

• Instrument downtime must be reduced

• Faster routine qualification is desired

• Equivalent qualification performance is required with shorter run times

Both systems are designed to provide equivalent qualification outcomes.

Supported Instrument Types

DIY HPLC qualification kits are compatible with:

• HPLC systems

• UHPLC systems operated under HPLC qualification protocols

• Isocratic systems

• Gradient systems

Supported detectors include:

• UV detectors

• Variable wavelength detectors

• PDA detectors

• DAD detectors

Optional detector qualification accessories are available for:

• Fluorescence detectors

• Refractive Index (RI) detectors

What Is Included In A Qualification Kit?

Each PQ™ or HSQ™ kit includes:

• NIST-traceable calibration solutions

• Certificate of Analysis (CoA)

• Certified qualification column

• Certificate of Performance

• Protected Excel™ calculation templates

• Qualification protocols

• Technical and educational support

Why Perform Qualification In-House?

Many laboratories perform qualification internally to:

• Schedule qualification as needed

• Reduce dependence on external service vendors

• Maintain audit readiness

• Integrate qualification into laboratory SOPs

• Monitor instrument performance throughout the year

• Support continuous compliance programs

Common Applications

DIY HPLC qualification kits are commonly used for:

• USP <1058> qualification programs

• Performance Qualification (PQ)

• HoX monitoring

• Instrument performance verification

• Internal quality programs

• Audit preparation

• Compliance documentation

• Detector performance monitoring

Frequently Asked Questions

• What is the difference between PQ™ and HSQ™?

  Both kits perform HPLC qualification. HSQ™ uses a shorter, high-efficiency qualification column that reduces run time while maintaining qualification performance.

• Does this kit support USP <1058> programs?

  Yes. These kits are commonly used in laboratories operating qualification programs that reference USP <1058> guidance.

• Can fluorescence detectors be qualified?

  Yes. Optional detector qualification accessories are available for fluorescence detectors.

• Can RI detectors be qualified?

  Yes. Optional detector qualification accessories are available for refractive index detectors.

• How long do qualification kits remain valid?

  Qualification materials are supplied with a minimum remaining shelf life at shipment, and the expiration period is two years from manufacture.

• Can these kits be incorporated into laboratory SOPs?

  Yes. Qualification protocols are designed to be incorporated into internal laboratory procedures and documentation systems.

Why Choose Chemical Solutions™ Qualification Kits?

• NIST-traceable standards

• Certified test columns

• Comprehensive qualification documentation

• DIY qualification flexibility

• USP <1058> support

• Audit-ready documentation

• Ongoing technical support

• Reduced qualification costs compared to outsourced services

Related Categories

• HPLC Columns & Hardware

• Chromatography Service & Instrument Maintenance Tools