Introduction
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.
Objective
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
Interface
- 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)
Read also:
- URS in Pharmaceutical Industry
- SOP for URS Preparation
- Template for URS Preparation
- Basic Knowledge on Chromatographic Techniques (HPLC & GC)
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