HPLC Performance Qualification System

What is the PQ Kit?

The HPLC Performance Qualification (PQ) Kit is designed to allow you to test and document your HPLC systems using NIST-Traceable standard reference materials.  A dedicated, premium test column is provided with the kit to ensure the scientific integrity of the test results.  Both Isocratic and Gradient Systems can be qualified, with Variable Wavelength or Diode Array detectors. 

The PQ System is comprised of 4 major components:

$ A series of NIST-Traceable calibration solutions, with Certificate of Analysis

$ The PQ Test Column - Pre-Tested for the test protocols with a Certificate

$ A Validated Excel^tm based software template (protected) to compile, calculate and graph the test results

$ A series of Test Protocols, which can be freely incorporated into your internal SOP’s

What Does it Test?

The PQ System tests your HPLC for the following performance characteristics:

The HPLC PQ Kit is:

< Compliant -         Build cGMP Compliance and NIST-Traceability into your laboratory qualification system.  The validated software is readily incorporated into your current document control system for 21 CFR 11 compliance.

< Scientific-             The PQ Test Protocols are scientifically sound, with full discussion and justification for their design and recommended Acceptance Criteria. Test Protocols are based on industry accepted practices.

< Universal-            By using a standardized test column, test solutions and test protocols, the data produced is universal.  This can help you troubleshoot Method Transfer and Reproducibility issues in your laboratories around the world by comparing instrument and laboratory performance under standardized conditions.

< Rapid-                  A typical Isocratic qualification requires  about 3 hours - Gradient qualifications take about 45 minutes per gradient solvent pair.

< Easy-                   All test solutions are pre-made - just prepare a simple binary mobile phase and start the runs.  Since the column is dedicated and stored in mobile phase, equilibration is rapid.  The Validated Software automatically compiles the required information, then calculates and graphs the results - the final printed results are ready for review and signoff.

< Flexible-               The PQ Test Protocols are flexible, and can be easily incorporated into your existing HPLC Performance Qualification SOP’s to help build an efficient and effective HPLC qualification procedure for your laboratory instruments.  The PQ Kit can also serve as a convenient training tool for new analysts. 

< Economical-         The PQ Kit is economical. Retail Price for the complete qualification kit with HPLC Test Column is $895.  Replacement solutions are $525.  There are no limits or restrictions on the number of HPLC systems that can be qualified with a single kit.   Customer support is always available at no charge.

Download PDF Operating Instruction Manual

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