Carbon11MethionineQualityChecker

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Carbon11MethionineQualityChecker for [11C]Methionine.

Domain limits and critical parameters

• ℹ️ The utility checks RCP, residual precursor, methyl iodide, sterility, endotoxins.
• ⚠️ CRITICAL! RCP ≥95%. Precursor ≤10 ppm. T½ = 20.4 min!
• • Radiochemical Purity: Must be ≥95%. Main impurities are unreacted [11C]methyl iodide and synthesis byproducts.
• • Residual Precursor: Toxic. Its content is strictly limited (≤10 ppm).
• • Methyl Iodide: Alkylating agent, must be removed almost completely (≤5 ppm).
• • Short Half-life: Requires rapid synthesis and QC. Sterility test is often performed retrospectively (after patient administration), but endotoxins must be checked before release.
• ⚠️ CRITICAL:
• • Radionuclidic Purity: ≥ 99.0%
• • Radiochemical Purity: ≥ 95.0%
• • Specific Activity: ≥ 10 GBq/umol
• • Precursor: ≤ 10 ppm
• • Methyl Iodide: ≤ 5 ppm
• • Solvent (e.g., Acetonitrile): ≤ 410 ppm
• • Endotoxins: ≤ 17.5 EU/mL

URS — User Requirements Specification

input.csv contract

BatchNumber,Radionuclidic_Purity_Percent,Radiochemical_Purity_Percent,Specific_Activity_GBq_umol,Precursor_Residue_ppm,Methyl_Iodide_Residue_ppm,Solvent_Residue_ppm,pH_Value,Osmolality_mOsm_kg,SterilityTest,Bacterial_Endotoxins_EU_per_mL,Appearance_Score,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
C11-MET-2026-001,99.9,98.5,40.0,2.0,0.5,100.0,6.5,290,0,5.0,0,0,0,0,0

FS — Functional Specification

Example output.json

{
  "utilityId": "carbon11-methionine-quality-checker",
  "api": "[11C]Methionine",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "C11-MET-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radionuclidic_Purity_Percent",
      "value": "99.9",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radiochemical_Purity_Percent",
      "value": "98.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Specific_Activity_GBq_umol",
      "value": "40.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Precursor_Residue_ppm",
      "value": "2.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Methyl_Iodide_Residue_ppm",
      "value": "0.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Solvent_Residue_ppm",
      "value": "100.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH_Value",
      "value": "6.5",
      "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.