Fluorat_B_Complex_Vitamins

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface, user requirements and functional behaviour of Fluorat_B_Complex_Vitamins. The utility is intended for automated verification of laboratory, pharmacopoeial, analytical or manufacturing QC parameters using input.csv and producing a structured output.json result.

Domain limits and critical parameters

• • Vitamin B2 (Riboflavin): 90–110% of Label Claim
• • Vitamin B6 (Pyridoxine): 90–110% of Label Claim
• • Vitamin B1 (Thiamine): 90–110% of Label Claim
• • Background Fluorescence: <10.0 a.u. (purity control)
• • Riboflavin (B2) has pronounced native fluorescence, allowing high-sensitivity determination without derivatization.
• • Thiamine (B1) and pyridoxine (B6) can also be determined fluorometrically, often after chemical conversion to fluorescent derivatives (e.g., thiochrome for B1).
• • Fluorometric analysis on Lumex instruments (Fluorat series) provides lower detection limits compared to UV spectroscopy.
• • Background control is necessary to exclude interference from impurities in solvents or cuvette materials.
• • B-group vitamins are light-sensitive (especially B2 and B6). All operations must be performed in dim light or under red light.
• • Solution pH strongly affects fluorescence intensity. Buffering is required.
• • Fluorescence quenching may occur in the presence of heavy metals or oxygen.
• • Calibration must be performed using fresh standard solutions.
• • High-sensitivity determination of riboflavin and other B vitamins.
• • Analysis quality control via background fluorescence parameter.
• • Support for Lumex Fluorat fluorometer data.
• • Vitamin B2: 90-110% LC

URS — User Requirements Specification

input.csv contract

BatchNumber,B2_mg_L,B6_mg_L,B1_mg_L,Background_Intensity
FLUOR-B-2026-001,5.2,4.8,5.1,2.5
FLUOR-B-2026-002,5.0,5.0,5.0,3.0
FLUOR-FAIL-2026-003,4.0,6.5,4.2,15.0

FS — Functional Specification

Example output.json

{
  "utilityId": "fluorat-b-complex-vitamins",
  "utilityName": "Fluorat_B_Complex_Vitamins",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "FLUOR-B-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "B2_mg_L",
      "value": "5.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "B6_mg_L",
      "value": "4.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "B1_mg_L",
      "value": "5.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Background_Intensity",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "generatedFor": "QA/QC review and LIMS integration"
}

Traceability matrix

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator, documentation and test set.
• Retain input.csv, output.json, executable version, documentation and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits must be verified against the approved specification, local SOPs and registration dossier.