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User Requirement Specification (URS) for HPLC


High performance liquid chromatography (HPLC) is an analytical requirement in pharmaceutical industry to confirm the identity and quantity of a molecule. This article will assist you to prepare the URS for HPLC.


To procure a HPLC to confirm the identity and quantity of a molecule.

Operational Requirements

  • High Pressure binary gradient two pump integrated system
  • The machine should be operable both in isocratic and gradient mode 
  • Should have possibility to operate in various gradient curve mode including Liner, Step, concave, convex etc.
  • Should have provision for housing at least four or more columns of 30 cm length
  • Should have provision of low noise performance within the operable wavelength range without lamp change
  • Light Source: Deuterium or tungsten lamp with minimum life of 2000 hrs or more
  • Operating modes: Direct Current pulsed amperometric detector (PAD) scan
  • Drift 1.0x10-4 AU
  • Sampling rate: Up to 80
  • Flow Cell Path length: 10mm, Cell volume: 16.3 μl or less
  • Potential Range: ±200mV in 10mV steps (DC, PAD, Scan)
  • Column Oven: 70° C above ambient to 450 °C, 0.10° c resolution.
  • Analog Signal Output: ± 1volt or: ± 10 volt selectable.
  • Auxiliary Electrode: Stainless steel.
  • Working Mode: DC
  • The system must be capable of handling pressures up to 40MPa

Technical Requirements

  • The flow rate should be within a range from 0.001 to 20 ml/min with the possibility of increment of 0.01 ml/min for carrying out semi-preparative applications
  • Flow Precision: ≤ 0.1% RSD or better
  • Flow Accuracy: ± 1.0% or better
  • Delay Volume : <200µl (with Mixer)
  • Max. Operating pressure: 6000 psi or more
  • Gradient Composition Accuracy: ± 0.5% of setting 1ml
  • Gradient Composition Precision: ± 0.5% of RSD of setting 1ml
  • Loop Size volumes should be of 5ul, 20ul, and 200 µl etc. with suitable syringe
  • Temperature setting rage: Ambient- 60°C or better
  • Operating temperature: ambient to 60°C or better
  • The detector should have wavelength range of 190-700 nm
  • Bandwidth <5 nm
  • Wavelength accuracy of ± 1 nm
  • Wavelength Repeatability: ± 0.1 nm
  • Linearity <5%at 2.4AU
  • Base line Noise single wavelength 5.0x10-6 AU at 230 nm or better
  • Base line Noise Dual wavelength 35.0x10-6 AU at 230nm, 280 nm or better
  • Filter time constants: 0.1-5 seconds in 1, 2, 5 sequence steps, DC mode
  • Current Range: DC 10pA (dummy load .47 Uf, 200Mohms, +800mV, time constant 1.0 s) at temperature equal 300 C
  • Range: 20nA-200uA, 1, 2, 5 sequence steps
  • t1: 100-2000 ms
  • t2: 100-2000 ms
  • t3: 0(off)-2000 ms in 10 ms steps
  • Sample times (ts)= 20, 40, 60, 80, 100 ms
  • Scan Range: 10nA-5uA in 1, 2, 5 steps
  • Scan Times: 1-50 Mv/s in 1, 2, 5 steps
  • Scan Cycles: Half, Full, Continuous
  • Time event programming: DC & PAD
  • Flow Cell: Design: Confined Wall-Jet
  • Standard flow cell: 0.08uL min. volume, flow rate 25uL/min-2mL/min


  • The software should be original and authenticated and the system should allow the easy integration of calibration data into data analysis methods
  • System should have option for data integrity along with advanced security measures Embedded Oracle data base software must be quoted.
  • Single point control/Single software must be quoted to control and acquire data from all the modules.
  • The data analysis information and report preparation with customized settings must be available. The report format should be either rtf or pdf format. The raw data may be extractable as a csv format or text file.

Life Cycle Requirements

  • Commissioning requirement
  • Qualification requirement
  • Maintenance
  • Training

Other Requirements as Appropriate

  • Type of construction
  • Materials to be used
  • Cleaning
  • Delivery
  • Traceability
  • Factory acceptance test (FAT)/Site acceptance test (SAT)

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Tags in: hplc urs template, urs preparation, urs sop, urs example.

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