URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of BismuthSubcitrateMetronidazoleTetracycline_GastroFDCQualityChecker for Bismuth/Metronidazole/Tetracycline Gastro FDC Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of H. pylori eradication combination:
• • Bismuth Assay: 90.0–110.0%
• • Metronidazole Assay: 90.0–110.0%
• • Tetracycline Assay: 90.0–110.0%
• • Metronidazole Impurities: ≤1.0%
• • Tetracycline Impurities: ≤1.0%
• • Total Impurities: ≤2.5%
• • Dissolution of each component: ≥85% (Q)
• • Moisture Content: ≤5.0%
• • Heavy Metals: ≤20 ppm
• ⚠️ CRITICAL: Tetracycline is sensitive to light and moisture (epi-tetracycline formation).
• BatchNumber,BismuthAssayPercent,MetronidazoleAssayPercent,TetracyclineAssayPercent,MetronidazoleImpurityPercent,TetracyclineImpurityPercent,TotalImpuritiesPercent,DissolutionMetronidazolePercent,DissolutionTetracyclinePercent,MoistureContentPercent,HeavyMetalsPPM
• ⚠️ CRITICAL:
• • Assay 90.0–110.0% for each component — ensures eradication efficacy
• • Metronidazole and Tetracycline impurities ≤1.0% — degradation and synthesis products
• • Total Impurities ≤2.5% — overall purity indicator
• • Dissolution ≥85% for each component — ensures bioavailability
• • Moisture Content ≤5.0% — critical for tetracycline stability

URS — User Requirements Specification

input.csv contract

BatchNumber,BismuthAssayPercent,MetronidazoleAssayPercent,TetracyclineAssayPercent,MetronidazoleImpurityPercent,TetracyclineImpurityPercent,TotalImpuritiesPercent,DissolutionMetronidazolePercent,DissolutionTetracyclinePercent,MoistureContentPercent,HeavyMetalsPPM
BMT-2026-001,100.5,99.8,100.2,0.3,0.4,0.9,95.0,92.0,3.5,8.0
BMT-2026-002,98.0,101.0,99.5,0.5,0.6,1.3,93.0,90.0,4.2,10.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "bismuth-subcitrate-metronidazole-tetracycline-gastro-fdc-quality-checker",
  "utilityFolder": "BismuthSubcitrateMetronidazoleTetracycline_GastroFDCQualityChecker",
  "package": "Gastroenterology QC Suite",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "BMT-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "BismuthAssayPercent",
      "value": "100.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "MetronidazoleAssayPercent",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "TetracyclineAssayPercent",
      "value": "100.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "MetronidazoleImpurityPercent",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "TetracyclineImpurityPercent",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "TotalImpuritiesPercent",
      "value": "0.9",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "DissolutionMetronidazolePercent",
      "value": "95.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "DissolutionTetracyclinePercent",
      "value": "92.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "MoistureContentPercent",
      "value": "3.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "HeavyMetalsPPM",
      "value": "8.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "BismuthSubcitrateMetronidazoleTetracycline_GastroFDCQualityChecker.documentation.html"
  }
}

Traceability matrix

IQ/OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating validator, documentation and test set.
• Retain input.csv, output.json, executable version and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
• For combination products, document whether the specialized FDC utility or fallback component checks were used.
• The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.