Specification builder · Tier D
High-performance liquid chromatography (HPLC) system with UV / PDA detection
An HPLC system pumps a liquid sample through a packed column to separate its components and measures each one with a UV or photodiode-array (PDA) detector. It is the main assay and impurity-testing instrument in pharmaceutical QC labs, drug testing laboratories, universities and food labs. Higher-pressure (UHPLC-capable) systems give faster runs and sharper peaks but cost more and need matching columns.
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Standards this specification draws on
- USP <621> Defines chromatography terms, system suitability parameters and allowed method adjustments that the CDS and system must support.
- Ph. Eur. 2.2.46 European pharmacopoeia chapter, harmonised with USP <621>, used by BP-based methods in Pakistan.
- ICH Q2(R2) Guideline for validating analytical procedures run on the HPLC (specificity, linearity, accuracy, precision, LOD/LOQ).
- ICH Q14 Analytical procedure development guideline; relevant for method development and lifecycle changes.
- USP <1058> Analytical instrument qualification framework (DQ/IQ/OQ/PQ) used to accept the system.
- 21 CFR Part 11 US FDA rule on electronic records and signatures; CDS audit trails and e-signatures are checked against it.
- EU GMP Annex 11 EU/PIC/S GMP rule for computerised systems; applies to the CDS in GMP labs.
- WHO TRS 1033 Annex 4 WHO guideline on data integrity, relevant for WHO-prequalification and DRAP GMP inspections.
- ASTM E1657 Standard practice for testing variable-wavelength photometric detectors (noise, drift, linearity) used in OQ.
- IEC 61010-1 Electrical safety standard for laboratory equipment.
- ISO/IEC 17025:2017 Accreditation standard for testing labs; requires qualified, calibrated equipment and controlled data.
Common mistakes in tenders for this equipment
- Copying one brand's datasheet numbers (for example an exact 1300 bar pressure, 190-950 nm range or a specific vial count) so only that brand can comply; state minimum needs with 'not less than' instead.
- Using proprietary names (light-pipe or cartridge flow cells, named flow-control or software features, a named CDS version) in the specification instead of measurable performance.
- Requiring the same CDS brand as existing instruments without stating this as a justified compatibility requirement; ask instead for control through the existing CDS or data export in open formats.
- Comparing detector noise and carryover figures measured under different test conditions; ask bidders to state the test conditions and verify at OQ.
- Accepting a 'Part 11 compliant' claim without a live demonstration of audit trail, user roles, e-signatures and protection against data deletion.
- Buying a 1000+ bar UHPLC for a QC lab that only runs 250 x 4.6 mm, 5 um pharmacopoeial methods; it costs more and gives no benefit.
- Leaving out columns, lamps, seals, vials, UPS and the service contract, so the instrument stands idle or service prices rise sharply after warranty.
- Asking for DRAP medical-device registration: an analytical HPLC is laboratory equipment, so this demand only confuses bidders.