URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of AlogliptinMetformin_Dpp4MetforminFDCQualityChecker for Alogliptin/Metformin DPP.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of alogliptin and metformin combination:
• • Alogliptin Assay: 90.0–110.0%
• • Metformin Assay: 90.0–110.0%
• • Alogliptin Impurities: ≤0.5%
• • Metformin Impurities: ≤0.5%
• • Total Impurities: ≤1.0%
• • Dissolution of each component: ≥85% (Q)
• • Loss on Drying: ≤5.0%
• • Heavy Metals: ≤20 ppm
• ⚠️ CRITICAL: Violation of content of any component reduces hypoglycemic effect.
• Metformin is hygroscopic — moisture control is critical.
• BatchNumber,AlogliptinAssayPercent,MetforminAssayPercent,AlogliptinImpurityPercent,MetforminImpurityPercent,TotalImpuritiesPercent,DissolutionAlogliptinPercent,DissolutionMetforminPercent,LossOnDryingPercent,HeavyMetalsPPM
• ⚠️ CRITICAL:
• • Assay 90.0–110.0% for each component — ensures therapeutic efficacy
• • Impurities ≤0.5% for each component — degradation and synthesis products
• • Total Impurities ≤1.0% — overall purity indicator of combination
• • Dissolution ≥85% for each component — ensures bioavailability
• • Loss on Drying ≤5.0% — critical due to metformin hygroscopicity

URS — User Requirements Specification

input.csv contract

BatchNumber,AlogliptinAssayPercent,MetforminAssayPercent,AlogliptinImpurityPercent,MetforminImpurityPercent,TotalImpuritiesPercent,DissolutionAlogliptinPercent,DissolutionMetforminPercent,LossOnDryingPercent,HeavyMetalsPPM
ALO-MET-2026-001,100.2,99.8,0.15,0.10,0.35,94.0,96.5,2.5,5.0
ALO-MET-2026-002,98.5,101.0,0.20,0.15,0.45,92.0,95.0,3.0,8.0

Input validation rules

FS — Functional Specification

Example output.json

{
  "utilityId": "alogliptin-metformin-dpp4-metformin-fdc-quality-checker",
  "utilityFolder": "AlogliptinMetformin_Dpp4MetforminFDCQualityChecker",
  "package": "Diabetes QC Suite",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-07-02T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ALO-MET-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "AlogliptinAssayPercent",
      "value": "100.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "MetforminAssayPercent",
      "value": "99.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "AlogliptinImpurityPercent",
      "value": "0.15",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "MetforminImpurityPercent",
      "value": "0.10",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "TotalImpuritiesPercent",
      "value": "0.35",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "DissolutionAlogliptinPercent",
      "value": "94.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "DissolutionMetforminPercent",
      "value": "96.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "LossOnDryingPercent",
      "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": "AlogliptinMetformin_Dpp4MetforminFDCQualityChecker.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.