URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of ArtesunateSulfadoxinePyrimethamineQualityChecker for Artesunate/Sulfadoxine/Pyrimethamine Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of artesunate, sulfadoxine, and pyrimethamine combination:
• • Artesunate Assay: 90.0–110.0%
• • Sulfadoxine Assay: 90.0–110.0%
• • Pyrimethamine Assay: 90.0–110.0%
• • Dihydroartemisinin (Impurity): ≤2.0%
• • Sulfadoxine Impurities: ≤1.0%
• • Pyrimethamine Impurities: ≤1.0%
• • Total Impurities: ≤3.5%
• • Dissolution of each component: ≥85% (Q)
• • Moisture Content: ≤5.0%
• • Heavy Metals: ≤20 ppm
• ⚠️ CRITICAL: Artesunate is highly unstable in humid environments. Sulfadoxine is sensitive to oxidation.
• BatchNumber,ArtesunateAssayPercent,SulfadoxineAssayPercent,PyrimethamineAssayPercent,DihydroartemisininPercent,SulfadoxineImpurityPercent,PyrimethamineImpurityPercent,TotalImpuritiesPercent,DissolutionArtesunatePercent,DissolutionSulfadoxinePercent,DissolutionPyrimethaminePercent,MoistureContentPercent,HeavyMetalsPPM
• ⚠️ CRITICAL:
• • Assay 90.0–110.0% for each component — ensures complete parasite eradication
• • Dihydroartemisinin ≤2.0% — main degradation product of artesunate
• • Sulfadoxine and Pyrimethamine impurities ≤1.0% each — synthesis and degradation products
• • Total Impurities ≤3.5% — overall purity indicator of complex combination

URS — User Requirements Specification

input.csv contract

BatchNumber,ArtesunateAssayPercent,SulfadoxineAssayPercent,PyrimethamineAssayPercent,DihydroartemisininPercent,SulfadoxineImpurityPercent,PyrimethamineImpurityPercent,TotalImpuritiesPercent,DissolutionArtesunatePercent,DissolutionSulfadoxinePercent,DissolutionPyrimethaminePercent,MoistureContentPercent,HeavyMetalsPPM
ART-SP-2026-001,100.5,99.8,100.2,1.0,0.4,0.3,2.0,93.0,95.0,94.5,3.2,5.0
ART-SP-2026-002,98.0,101.5,99.0,1.8,0.6,0.5,3.2,90.0,92.0,91.0,4.5,8.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "artesunate-sulfadoxine-pyrimethamine-quality-checker",
  "utilityFolder": "ArtesunateSulfadoxinePyrimethamineQualityChecker",
  "package": "Global/API coverage extension",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ART-SP-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "ArtesunateAssayPercent",
      "value": "100.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "SulfadoxineAssayPercent",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "PyrimethamineAssayPercent",
      "value": "100.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "DihydroartemisininPercent",
      "value": "1.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "SulfadoxineImpurityPercent",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "PyrimethamineImpurityPercent",
      "value": "0.3",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "TotalImpuritiesPercent",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "DissolutionArtesunatePercent",
      "value": "93.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "DissolutionSulfadoxinePercent",
      "value": "95.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "DissolutionPyrimethaminePercent",
      "value": "94.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    },
    {
      "parameter": "MoistureContentPercent",
      "value": "3.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-012"
    },
    {
      "parameter": "HeavyMetalsPPM",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-013"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "ArtesunateSulfadoxinePyrimethamineQualityChecker.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.