Phosphorus32OrthophosphateChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Phosphorus32OrthophosphateChecker for Phosphorus-32 Orthophosphate.

Domain limits and critical parameters

• ℹ️ Utility checks critical parameters of Phosphorus-32 solution:
• • Radionuclidic purity (≥99.9%)
• • Phosphorus-33 impurity (≤0.1%)
• • Radiochemical purity (≥95%, orthophosphate form)
• • pH, endotoxins, sterility
• ⚠️ CRITICAL: Product MUST BE in ORTHOPHOSPHATE form for bone uptake!
• P-33 impurity is undesirable due to long half-life.
• Sterility is mandatory even for oral forms (due to systemic action).
• BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Phosphorus33ImpurityPercent,RadiochemicalPurityPercent,pH,EndotoxinsEU,SterilityTest,OsmolalityMOsmKg,ProductType
• Example (sterility: 0=sterile, 1=contaminated):
• ⚠️ CRITICAL:
• • Radiochemical purity ≥95% (orthophosphate form) — IF phosphorus is in another chemical form (e.g., polyphosphate or colloid), it will NOT be properly absorbed by bone tissue and will not have therapeutic effect, or may accumulate in liver/spleen.
• • Phosphorus-33 impurity ≤0.1% — P-33 (T½=25.3 days) creates additional burden on bone marrow without therapeutic benefit.
• • Sterility — MANDATORY. Even with oral administration, the drug is absorbed into blood and delivered to bone marrow. Contamination is unacceptable.

URS — User Requirements Specification

input.csv contract

BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Phosphorus33ImpurityPercent,RadiochemicalPurityPercent,pH,EndotoxinsEU,SterilityTest,OsmolalityMOsmKg,ProductType
P32-ORTHO-2026-010,185.0,99.95,0.05,99.0,6.5,40.0,0,300,IVInjection
P32-ORAL-2026-002,370.0,99.9,0.1,98.5,7.0,100.0,0,290,OralSolution
P32-ORTHO-2026-011,180.0,99.5,0.5,90.0,6.0,50.0,0,310,IVInjection

FS — Functional Specification

Example output.json

{
  "utilityId": "phosphorus32-orthophosphate-checker",
  "api": "Phosphorus-32 Orthophosphate",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "P32-ORTHO-2026-010",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "185.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadionuclidicPurityPercent",
      "value": "99.95",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Phosphorus33ImpurityPercent",
      "value": "0.05",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "99.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "6.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "40.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SterilityTest",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator 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 radiopharmaceutical limits must be verified against the approved specification and local SOPs.