I131SodiumIodideTherapyQC

I-131 Sodium Iodide Therapy QC — Quality control of therapeutic Iodine-131

ℹ️ Utility checks critical parameters of I-131 NaI:

• Radiochemical purity (≥95%)
• Free iodine (≤5%)
• Volatile iodine forms (<1%) — RADIATION SAFETY!
• Specific activity, pH, endotoxins, sterility

⚠️ CRITICAL: Free iodine irritates GI tract and is not taken up by thyroid!

I-131 is used for thyroid ablation and cancer treatment.

Alkaline pH is critical to prevent iodide oxidation to volatile iodine.

Usage

I131SodiumIodideTherapyQC.exe → demo mode (console output)

I131SodiumIodideTherapyQC.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,FreeIodinePercent,pH,SpecificActivityMBq_per_mg,EndotoxinsEU_per_mL,SterilityTest,ActivityGBq,RadionuclidicPurityPercent,Te131ImpurityPercent,VolatileIodinePercent

Example

I131-NaI-THER-2026-001,99.5,0.2,8.0,500000.0,10.0,0,7.4,99.99,0.0001,0.05

— WHY IS THIS NEEDED?

I-131 NaI is main drug for hyperthyroidism and differentiated thyroid cancer therapy.

• I-131 emits beta particles destroying thyrocytes.
• Half-life 8.02 days.
• Requires high radiochemical purity as only iodide (I-) is actively taken up by sodium-iodide symporter (NIS).
• Free molecular iodine (I2) is toxic to gastric mucosa and has no therapeutic effect.

⚠️ CRITICAL:

• Radiochemical purity ≥95% — guarantee of dose delivery to target organ.
• Free iodine ≤5% — minimization of GI side effects.
• Volatile iodine forms <1% — critical for radiation safety of staff and patient (inhalation risk).
• pH 7.0-10.0 — alkaline media stabilizes solution, preventing I- oxidation to I2.
• Specific activity must be very high (>100 GBq/mg) so that mass of administered substance is negligible.
• Te-131 impurity <0.001% — Te-131 is parent nuclide, its presence indicates incomplete purification.
• Endotoxins <175 EU/mL — standard for parenteral drugs.
• Sterility — MANDATORY.

Key features

• Strict control of volatile iodine forms, unique for I-131.
• Assessment of free iodine content, critical for oral administration.
• Alkaline pH check as stability factor.
• Compliance with GMP and Pharmacopoeia requirements for I-131.
• Comprehensive safety check (endotoxins, sterility).

Critical parameters

• Radiochemical purity: ≥95.0%
• Free iodine: ≤5.0%
• Volatile iodine forms: <1.0%
• Specific activity: ≥100,000 MBq/mg
• Radionuclidic purity: ≥99.9%
• Te-131 impurity: <0.001%
• pH: 7.0–10.0
• Endotoxins: <175 EU/mL
• Sterility: no growth

💡 Usage tips:

1. Radiochemical purity determined by TLC (silica gel/methanol).

2. Volatile iodine forms controlled by adsorption on activated carbon or silver wool.

3. Drug must be stored in tightly closed vials in fume hood.

4. Patients are recommended to drink plenty of fluids for rapid excretion of unbound iodine.

5. Due to high energy deposition, solution may heat up, accelerating oxidation, so pH control is important.

⚠️ Note: I-131 therapy requires special attention to radiation hygiene. Presence of volatile iodine in drug creates risk of air contamination in wards and patient excreta, requiring special precautions. This utility helps ensure that drug is safe not only for patient but also for surrounding environment.