RadiolysisStabilityChecker

1. Scope

This document defines requirements and functional behaviour for RadiolysisStabilityChecker used to control: Radiolysis Stability Checker. The utility is intended for QC use and applies deterministic rules, not machine learning.

2. Execution modes

• RadiolysisStabilityChecker.exe — demo mode or help output.
• RadiolysisStabilityChecker.exe input.csv output.json — process user data and write result.

3. Key source-derived controls

• Radiolysis Stability Checker — Radiopharmaceutical Stability Assessment
• BatchNumber,Radiopharmaceutical,Initial_Activity_MBq,Volume_mL,Initial_RCP_Percent,Has_Radioprotector,Radioprotector_Type,Radioprotector_Concentration_mM,EOS_Time_ISO,Check_Time_ISO,Radionuclide
• At high specific activities, radiopharmaceuticals are subject to radiolysis — self-decomposition by their own radiation.
• • Prediction: The utility estimates how much Radiochemical Purity (RCP) will drop by the time of injection or expiration.
• • Alpha Emitters (Ac-225): Have high LET (Linear Energy Transfer), causing rapid radiolysis even at low activities.
• ⚠️ IMPORTANT:
• • The model is simplified. Real radiolysis kinetics are complex and depend on many factors (pH, impurities, vial material).

4. URS — user requirements

5. input.csv contract

BatchNumber,Radiopharmaceutical,Initial_Activity_MBq,Volume_mL,Initial_RCP_Percent,Has_Radioprotector,Radioprotector_Type,Radioprotector_Concentration_mM,EOS_Time_ISO,Check_Time_ISO,Radionuclide
LU177-STAB-001,Lu-177-DOTATATE,7400.0,5.0,99.5,true,Ascorbic,10.0,2026-05-20T08:00:00,2026-05-20T16:00:00,Lu-177
AC225-STAB-001,Ac-225-PSMA,10.0,1.0,98.0,false,None,0.0,2026-05-20T08:00:00,2026-05-20T12:00:00,Ac-225

6. FS — functional specification

7. output.json example

{
  "utilityId": "radiolysis-stability-checker",
  "api": "Radiolysis Stability Checker",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "LU177-STAB-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiopharmaceutical",
      "value": "Lu-177-DOTATATE",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Initial_Activity_MBq",
      "value": "7400.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Volume_mL",
      "value": "5.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Initial_RCP_Percent",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Has_Radioprotector",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radioprotector_Type",
      "value": "Ascorbic",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radioprotector_Concentration_mM",
      "value": "10.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

8. OQ/PQ test scenarios

9. QA/QC and change control

• Do not rename columns without validator update.
• Store 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 checked against the approved specification and local SOPs.