FSSAI advisory QA-11013/1/2025-QA-FSSAI · 17 Jul 2026
Official title
Approved Technical specifications of High End Equipment (HEE) –LC-HRMS
Official record
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Check the official recordThe Food Safety and Standards Authority of India (FSSAI) provides indicative technical specifications for High End Equipment (HEE) LC-HRMS systems. These specifications serve as a guide for procuring agencies to assess operational needs for food, feed, and water contaminant analysis. The document outlines requirements for the UHPLC system, mass spectrometer, workstation software, and mandatory accessories. These guidelines are not mandatory tender specifications. Procuring agencies must independently evaluate their requirements and may consult technical committees or experts. FSSAI does not assume liability for procurement or contractual issues arising from these specifications. Agencies must ensure that procurement processes remain fair and do not favor specific manufacturers or technologies.
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QA-11013/1/2025-QA-FSSAI
I/39899/2026
फ़ाइल संख्या: QA-11013/1/2025-QA-FSSAI
भारतीय खाद्य सुरक्षा एवं मानक प्राधिकरण
(खाद्य सुरक्षा एवं मानक अधिनिनयम, 2006 के अंतर्गत स्थापित एक वैज्ञानिक प्राधिकरण)
(गुणवत्ता आश्वासन प्रभाग)
एफ.डी.ए, भवन, कोटला रोड, नई दिल्ली – 110002
दिनांक: 17^th July, 2026
सूचना / Notice
Subject: Technical specifications of High End Equipment (HEE) –LC-HRMS– reg.
FSSAI has finalized the technical specifications of High End Equipment (HEE) –LC - HRMS. The suggestive technical specifications of LC-HRMS, are placed at Annexure-I.
2. The specifications are purely indicative and shall not be construed as standard tender specifications or mandatory procurement conditions. The procuring agencies shall independently assess their operational requirements and suitably modify any specification thereof, as deemed necessary. Further, nothing contained in the enclosed specifications shall be interpreted as favouring or restricting any particular manufacturer, technology, supplier or country of origin. Wherever required, procuring agencies may constitute their own Technical Committee (TEC) or consult subject matter experts for finalization of tender specifications. FSSAI shall not be liable for any procurement/ contractual issues arising out of procurement undertaken by other agencies.
Digitally signed by
Abhinay Shashank
Date: 17-07-2026
11:35:33
(अभिनय शशांक)
सहायक निदेशक (तकनीकी)
ईमेल: abhinay.shashank@fssai.gov.in
Copy To -
Annexure-I
| Technical Specifications of LC-HRMS |
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| 9 |
Application Notes showing pesticide/ antibiotic residue analysis at less than 5 ppb method LOQ, should be provided and demonstrated. | | | (ii) In this regard document showing calibration curves for relevant contaminants (pesticides/antibiotics) in DIA and high-res MRM mode must be provided. | | 10 | (i) Acquisition modes: | | | (a) The system must have variable window acquisition mode in Q1 for Data Independent Acquisition (DIA) | | | (b) Must acquire and display Full Scan mass spectra | | | (c) Must acquire and display Selected Ion Monitoring (SIM) scan data for monitoring selected ions for target compound analysis | | | (d) Must acquire and Multiple Reaction Monitoring (MRM/PRM) like Selected Reaction Monitoring/Multiple Reaction Monitoring (SRM/MRM) like data sets | | | (e) Timed SIM for scheduled data acquisition of target compounds | | | (f) Timed MS/MS for scheduled data acquisition of target compound fragment spectra | | | (g) Must have Dynamic Exclusion capability on fly to temporarily exclude an ion, while allowing MS/MS spectra acquisition of minor abundant precursors | | 11 | Dynamic range: The system should have linear dynamic range of 5 orders or better for Qualitative and relative Quantitative analysis with the highest sensitivity, claimed mass accuracy, precision and reproducibility. | | | Workstation and Software | | 12 | Original and Licensed Universal perpetual software (Including free upgrades up to 5years) | | 13 | Computers and workstations and all interfacing hardware and software for instrument control, data acquisition and data processing must be supplied and should be compatible to the system. | | 14 | (i) Acquisition Computer-1 nos. with the following / equivalent or higher configuration: | | | (ii) High-performance PC with factory recommended processor and OS, MS office professional, minimum 32 GB RAM, minimum 2 TB HDD or better, High-resolution 24” LED monitor, wireless keyboard & mouse | | 15 | (i) Processing computer- 1 no. with the following/equivalent or higher configuration: | | | (ii) High-performance PC with Intel i7 microprocessor, Windows 10 professional OS, 64 GB RAM, MS office professional, 10 TB HDD, High-resolution 28” LED monitor, wireless keyboard & mouse and Laser printer Duplex printing /copy ( print, copy, scan). | | 16 | Operating Software: The software should be user friendly, capable of controlling the entire functions of UHPLC and HRMS/MS, with required licenses for systems suitability calculations; all accessories required for its operation should be provided. Full-fledged reporting facility with capability of customized user-designed report format should be available. | | 17 | (i) Application Software: Application software for complete workflows like targeted and untargeted screening, library search, elemental composition algorithm, component differential analysis, back ground subtraction etc. Dedicated software for small molecules and non-targeted compound analysis with suitable data library must be provided.: | | | (ii) Empirical formula: from the m/z value from spectra with algorithm for better matching. | | | (iii) Fragment prediction: For metabolite identification - Ability to store data dependent information as trees and search (navigation) Component detection & Predict fragmentation with mechanisms. Software with HRMS database should be provided . | | | (iv) Compound database: should have up to date compound HRMS libraries and fragments with different energies of collision dissociation. All library and software should be included for the above-mentioned applications (Pesticides, Antibiotics, Small Molecules) | | | (v) Quoted Application software should come with In-built MS acquisition workflows for Metabolomics applications (Targeted & Non- Targeted workflows), including lipidomics, either in the same software or dedicated lipidomics software. | | | (a) Ready to-use acquisition and data processing methods ( with supply of Pre-defined columns, QC samples and settings) for targeted screening and quantitation of at least 300 contaminants, which should be pre-configured and work at customer site directly after installation | | | (b) Automatic library searching against Free and commercially available libraries | | | (c) Automatic library searching against user defined libraries | | | (d) Qualitative, quantitative and characterization with suitable library system. | | | (e) Standard Operating Procedures for multi-target screening and quantitation included in the package for food safety applications | | | (f) Indicators and scoring in the software based on annotation quality of mass and retention data for identified compounds in targeted analysis | | | (g) Data acquisition and data processing that ensures that even trace amounts can be detected from complex matrices in screening experiments at a sub ppb level for certain compounds | | | (h) Availability and software support for both library search and database searches | | | (i) Database contains accurate mass information for both parent and MS/MS fragment ions, to be used for verification and reduction of false positives | | | (j) Possibility for metabolic pathway driven workflows for automatic generation of relevant target list for screening and subsequent quantitation | | | (k) Possibility in the software to choose which MS or MS/MS ion should be used for quantitation | | | (l) Possibility to easily adapt the target database; merge databases, reduce the number of entries, add new entries | | | (m) Software for non-targeted workflows and exploration of unknown compounds, metabolic pathways and statistical comparisons: | | | - Ions belonging to the same compound can be combined into one feature, i.e. isotopes, charge states, adducts or fragments. | | | - Rapid known-compound recognition, also called de-replication: The annotation quality symbol (AQ) gives at-a-glance indication if an identified compound is of high, medium or low quality. This allows a rapid assessment to confirm an assignment or to explore further characterization. | | | - Advanced statistical tools included in the software; e.g. PCA, ANOVA, T-Test, HCA | | | - Compound identification via spectral libraries and/or web search for possible structures based on unique elemental compositions automatically generated followed by in-silico fragmentation routines | | | (n) Client/server-based processing software solutions to ensure fast processing and remote access to data. | | | (o) Dedicated export options of results to enable a seamless data evaluation in 3rd party tools, e.g. for advanced statistics, pathway mapping or network analysis | | | (p) Single Software package should be able to compile data from all the mass analyzers and group the overlapping results to present a comprehensive report of all identified analytes without need to change the file format | | | (q) Software should allow discrimination of false discovery and allow grouping of environmental pollutants to reduce complexity in results. | | | (r) Metabolomics integrated software to understand the biological context of identified metabolites with statistical analysis capability: Ex: PCA plots and related statistical outputs. | | | Other mandatory general requirement | | 18 | Vendor should attend service call within 48 h free of cost during the 5 year warranty period. An affirmation in suitable stamp paper is required in this regard. Minimum one user reference letter certifying satisfactory instrument performance and service experience must be provided. | | | Vacuum System | | 19 | (i) A robust high efficiency oil less vacuum system with minimum maintenance and utility with low noise level and automatic vacuum lock system. | | | (ii) The system should have vacuum safety features to prevent damage to the instrument | | | (iii) All accessories required for the proper functioning of the vacuum should be supplied | | | Gases, cylinders and connections | | 20 | (i) Must be supplied with branded nitrogen gas generator of minimum 99.9% purity and flow rate as required for the HRMS instrument should be provided. | | | (ii) It should be complete with all necessary accessories such as arrangement for gas supply through the gas generator, compressor, gas regulators and filters. | | | (iii) Connector between gas generator and the system that are essential for the running of the instrument should be provided. | | | (iv) If any other gas is required for example collision gas should be mentioned and provided with minimum two gas cylinders, regulator, connectors etc. | | | (v) The gas supply system should not occupy excessive space, should have minimum tubing and maintain the aesthetics and functionality of the laboratory. An affirmation in this regard is required. | | | (vi) The following documents should be supplied along with the cylinder: | | | (a) Manufacturer Certificate; | | | (b) Hydrostatic test certificate; | | | (c) The Chief Controller of Explosives, Nagpur (CCOE-NAGPUR) gas filling approval certificate and | | | (d) Purity certificate. | | | UPS | | 21 | Online 20 KVA (or better) UPS with a minimum of 2 hour power back up for the entire system including the vacuum pump, nitrogen generator should be quoted. The battery must be placed in a suitable rack and the necessary accessories for power point connections should be provided. | | | Warranty and CMC | | 22 | (i) Minimum 5 years including supporting accessories, from the date of completion of IQ, OQ and PQ of system for honey authenticity and pesticide and antibiotic residues. | | | (ii) The heated ion source (ESI/ APCI) & Detector should be covered with 10 years warranty. | | | (iii) The date of warranty period for LC-HRMS, Nitrogen generator-compressor, vacuum system, UPS with batteries, PC, Printer, Gas cylinders with its accessories and all associated supply will start from the date of completion of IQ, OQ and PQ of LC-HRMS. | | | (iv) It should cover hardware, software as well as wear and tear consumables (except column and sample preparation), Up-gradation of software to the latest version (if applicable), prompt service (within 24-48 hours on-call), training and application support during the period. |