DIY HPLC Qualification Kits | PQ™ & HSQ™ for USP <1058> Compliance

DIY HPLC qualification kits are designed to support in‑house performance qualification (PQ) and Health‑of‑System (HoX) verification for liquid chromatography instruments. This category includes the Chemical Solutions™ PQ™ and HSQ™ qualification kits, enabling laboratories to test, document, and maintain instrument accuracy and precision using certified, NIST‑traceable materials.

These kits are used by regulated laboratories to support USP <1058>‑aligned qualification programs without relying on external service providers, allowing qualification to be performed on demand and on internal schedules.

Designed for Do‑It‑Yourself Qualification

The Chemical Solutions™ DIY qualification kits are engineered for laboratories that want full control over instrument qualification while maintaining scientific rigor and regulatory alignment.

Using these kits, laboratories can:

• Perform routine performance qualification (PQ)

• Conduct HoX (Health‑of‑System) checks

• Maintain documented instrument performance between audits

• Integrate qualification protocols into internal SOPs

The kits are suitable for isocratic and gradient HPLC systems equipped with:

• Variable‑wavelength UV detectors

• PDA/DAD detectors

Accessory kits are available to extend qualification to fluorescence and refractive‑index (RI) detectors.

PQ™ vs HSQ™ – Choosing the Right Kit

Both PQ™ and HSQ™ kits deliver equivalent qualification outcomes; the difference lies in execution time.

• PQ™ Kit Uses a standard‑length test column (150 × 4.6 mm) for comprehensive, traditional PQ workflows.

• HSQ™ Kit (High‑Speed Qualification) Uses a shorter, high‑efficiency test column (75 × 4.6 mm) to dramatically reduce run time while maintaining validated performance metrics.

The HSQ™ kit is ideal for laboratories seeking faster qualification without compromising data integrity.

What’s Included in Each DIY HPLC Qualification Kit

Each PQ™ or HSQ™ kit contains five core components designed to ensure traceability, consistency, and documentation:

• NIST‑Traceable Calibration Solutions Supplied with a Certificate of Analysis (CoA) for audit and compliance documentation.

• Certified Test Column (PQ™ or HSQ™) Pre‑validated for qualification protocols and supplied with a Certificate of Performance.

• Validated, Protected Excel™ Template Used to compile data, perform calculations, generate graphs, and document results consistently.

• Qualification Test Protocols Written protocols that can be freely incorporated into internal SOPs.

• Unlimited Technical & Educational Support Direct support to ensure correct execution, interpretation, and continued confidence in results.

Detector Expansion Kits

The base HPLC qualification kits are designed for UV and PDA detection. Accessory kits are available to qualify:

• Fluorescence detectors

• Refractive‑index (RI) detectors

These detector‑specific kits are used in conjunction with the HPLC PQ™ or HSQ™ kits to extend qualification coverage across multiple detector types.

Regulatory & Compliance Context

DIY HPLC qualification kits are commonly used to support:

• USP <1058> compliance frameworks

• Internal IQ/OQ/PQ programs

• Routine performance verification

• HoX and system trending

• Inspection and audit readiness

By performing qualification internally, laboratories maintain continuous compliance rather than periodic, service‑driven validation.

Kit Shelf Life & Usage

• Kits are supplied with a minimum of six months remaining shelf life at the time of shipment.

• Qualification materials are intended for prompt and repeated use.

• The expiration date is two years from the date of manufacture.

Additional Resources

• 👉 View HSQ™ Kit contents and technical specifications

• 👉 DIY HPLC Qualification Guides & Best Practices

Related Categories

• HPLC Columns & Hardware

• Chromatography Service & Instrument Maintenance Tools