Samarium153EDTMPQualityChecker

Utility description: Samarium-153 EDTMP

Samarium-153 EDTMP Quality Checker — Samarium-153 EDTMP (Quadramet) for Palliative Therapy

ℹ️  Utility checks critical parameters of Samarium-153 EDTMP:
    • Radionuclidic purity (≥99.9%)
    • Europium-154/155 impurities (≤0.1%) — LONG-LIVED!
    • Radiochemical purity (≥95%)
    • Free Samarium (≤5%)
    • pH, endotoxins, sterility

⚠️  CRITICAL: Free Samarium does NOT go to bones, but accumulates in the LIVER!
    Europium impurities create unnecessary gamma burden for years.

Usage:
  Samarium153EDTMPQualityChecker.exe                            → demo mode (console output)
  Samarium153EDTMPQualityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,TotalActivityMBq,RadionuclidicPurityPercent,Europium154ImpurityPercent,Europium155ImpurityPercent,RadiochemicalPurityPercent,FreeSamariumPercent,pH,EndotoxinsEU,SterilityTest,ProductType

Example (sterility: 0=sterile, 1=contaminated):
  SM153-EDTMP-2026-042,3700.0,99.95,0.001,0.002,98.5,1.5,7.2,40.0,0,TherapeuticDose

Supported product types:
• TherapeuticDose — therapeutic dose for bone pain relief

— WHY IS THIS NEEDED?
Samarium-153 complexed with ethylenediaminetetramethylene phosphonic acid (EDTMP/Quadramet®) is used for palliative treatment of bone metastasis pain:
• 46.3-hour half-life (1.9 days) — convenient for logistics and therapy
• Beta radiation (E_max = 0.81 MeV) — therapeutic effect in bone tissue
• Gamma radiation (103 keV) — allows scintigraphy to confirm bone uptake
• Selectively accumulates in areas of osteoblastic activity (metastases)

⚠️  CRITICAL:
• Radiochemical purity ≥95% — Sm-153-EDTMP complex is stable. If complex is broken or not formed, free Samarium ion (Sm3+) behaves like other lanthanides: it is rapidly captured by transferrin and accumulates in the LIVER and spleen, not bones. This reduces therapy efficacy and increases liver dose.
• Europium-154 (T½=8.6 years) and Europium-155 (T½=4.76 years) impurities — Formed during reactor irradiation. Even trace amounts (>0.1%) are unacceptable as they create long-term gamma burden on the patient after main drug clearance.
• pH 6.0–8.0 — Physiological range. Acidic solution causes pain on injection and may destabilize complex.
• Endotoxins ≤175 EU/vial — Standard for injectable radiopharmaceuticals.
• Sterility — MANDATORY.

Key features:
• Control of long-lived Europium impurities (Eu-154, Eu-155)
• Assessment of complexation efficiency (free Sm vs bound Sm)
• Suitability check for palliative care

Critical parameters:
• Radionuclidic purity: ≥99.9%
• Eu-154 impurity: ≤0.1%
• Eu-155 impurity: ≤0.1%
• Radiochemical purity (Sm-EDTMP): ≥95.0%
• Free Samarium: ≤5.0%
• pH: 6.0–8.0
• Endotoxins: ≤175 EU/vial
• Sterility: no microbial growth

💡 Usage tips:
1. Radiochemical purity controlled by TLC (solvent systems: ammonium citrate/methanol etc.). Free Sm stays at origin, complex moves with solvent front.
2. Presence of free Sm-153 is visible on scintigram as "hot" liver.
3. Drug must be administered within hours after preparation/receipt due to short half-life.
4. Patients should be hydrated to accelerate excretion of unbound drug via kidneys.

⚠️ Note: Unlike diagnostic technetium drugs, Sm-153 EDTMP is a THERAPEUTIC agent. Quality error (high free Sm) leads not just to bad image, but to lack of analgesic effect and liver toxicity. Eu-154/155 impurities make the drug a source of long-term radiation contamination of the patient.