URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of AtorvastatinEzetimibe_StatinEzetimibeFDCQualityChecker for Atorvastatin/Ezetimibe Statin/Ezetimibe FDC Quality Checker.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of atorvastatin and ezetimibe combination:
• • Atorvastatin Assay: 90.0–110.0%
• • Ezetimibe Assay: 90.0–110.0%
• • Atorvastatin Impurities: ≤1.5%
• • Ezetimibe Impurities: ≤1.0%
• • Total Impurities: ≤2.5%
• • Dissolution of each component: ≥85% (Q)
• • Moisture Content: ≤4.0%
• • Heavy Metals: ≤20 ppm
• ⚠️ CRITICAL: Atorvastatin is sensitive to oxidation and moisture. Ezetimibe has low solubility.
• Moisture control is critical to prevent statin degradation.
• BatchNumber,AtorvastatinAssayPercent,EzetimibeAssayPercent,AtorvastatinImpurityPercent,EzetimibeImpurityPercent,TotalImpuritiesPercent,DissolutionAtorvastatinPercent,DissolutionEzetimibePercent,MoistureContentPercent,HeavyMetalsPPM
• • Ezetimibe is poorly water-soluble, requiring dissolution control
• ⚠️ CRITICAL:
• • Assay 90.0–110.0% for each component — ensures lipid-lowering effect
• • Atorvastatin impurities ≤1.5% — oxidation and hydrolysis products
• • Ezetimibe impurities ≤1.0% — synthesis and degradation products
• • Total Impurities ≤2.5% — overall purity indicator

URS — User Requirements Specification

input.csv contract

BatchNumber,AtorvastatinAssayPercent,EzetimibeAssayPercent,AtorvastatinImpurityPercent,EzetimibeImpurityPercent,TotalImpuritiesPercent,DissolutionAtorvastatinPercent,DissolutionEzetimibePercent,MoistureContentPercent,HeavyMetalsPPM
ATV-EZE-2026-001,100.2,99.5,0.6,0.4,1.2,93.0,91.5,2.5,5.0
ATV-EZE-2026-002,98.0,101.0,0.8,0.5,1.5,90.0,89.0,3.2,8.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "atorvastatin-ezetimibe-statin-ezetimibe-fdc-quality-checker",
  "utilityFolder": "AtorvastatinEzetimibe_StatinEzetimibeFDCQualityChecker",
  "package": "Cardiology QC Suite",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ATV-EZE-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "AtorvastatinAssayPercent",
      "value": "100.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "EzetimibeAssayPercent",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "AtorvastatinImpurityPercent",
      "value": "0.6",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "EzetimibeImpurityPercent",
      "value": "0.4",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "TotalImpuritiesPercent",
      "value": "1.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "DissolutionAtorvastatinPercent",
      "value": "93.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "DissolutionEzetimibePercent",
      "value": "91.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "MoistureContentPercent",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "HeavyMetalsPPM",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "AtorvastatinEzetimibe_StatinEzetimibeFDCQualityChecker.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.