Tc99mNanocolloidParticleSizeAnalyzer

Tc-99m Nanocolloid Particle Size Analyzer — Particle size analysis of Tc-99m Nanocolloid

ℹ️ Utility checks critical particle size parameters of Tc-99m Nanocolloid:

• Mean size (<80 nm)
• D90 (<100 nm)
• Polydispersity index (PDI <0.2)
• Aggregates (<1%)

⚠️ CRITICAL: Large particles do not pass through lymphatic capillaries!

Tc-99m Nanocolloid is used for sentinel lymph node biopsy.

Particles >100 nm may get stuck at injection site or enter lungs.

Usage

Tc99mNanocolloidParticleSizeAnalyzer.exe → demo mode (console output)

Tc99mNanocolloidParticleSizeAnalyzer.exe input.csv output.json → evaluate your data

Input format

BatchNumber,MeanParticleSizeNm,ParticleSizeD90Nm,PolydispersityIndex,RadiochemicalPurityPercent,FreeTechnetiumPercent,AggregatesPercent,pH,ActivityMBq,SterilityTest,EndotoxinsEU_per_mL

Example

NANO-2026-001,40.0,60.0,0.15,98.0,1.0,0.5,7.0,500.0,0,10.0

— WHY IS THIS NEEDED?

Tc-99m Nanocolloid (albumin) is drug for lymphoscintigraphy and sentinel lymph node biopsy.

• Mechanism: drainage via lymphatic vessels due to small particle size.
• Particle size is critical: too small enter blood quickly, too large get stuck.
• Optimal range: 10-80 nm.
• Requires strict control of aggregation.

⚠️ CRITICAL:

• Mean particle size <80 nm — guarantee of passage through lymphatic capillaries.
• D90 <100 nm — absence of large fraction that may cause embolism.
• PDI <0.2 — suspension uniformity.
• Aggregates <1% — minimization of pulmonary embolism risk.
• Radiochemical purity ≥95% — specificity of accumulation in lymph nodes.
• Free technetium <5% — background minimization.
• pH 6.0-8.0 — colloid stability.
• Endotoxins <175 EU/mL — standard for parenteral drugs.
• Sterility — MANDATORY.

Key features

• Detailed analysis of particle size distribution (Mean, D90).
• Polydispersity (PDI) control.
• Assessment of aggregate fraction, critical for safety.
• Compliance with GMP requirements for nano-radiopharmaceuticals.
• Comprehensive safety check (endotoxins, sterility, pH).

Critical parameters

• Mean particle size: <80 nm
• D90: <100 nm
• PDI: <0.2
• Aggregates: <1.0%
• Radiochemical purity: ≥95.0%
• Free technetium: <5.0%
• pH: 6.0–8.0
• Endotoxins: <175 EU/mL
• Sterility: no growth

💡 Usage tips:

1. Particle size determined by dynamic light scattering (DLS) or electron microscopy.

2. Drug should be stored at 2-8°C, but brought to room temperature before administration.

3. Do not shake vigorously to avoid foam and aggregate formation.

4. Administer subcutaneously or peritumorally depending on protocol.

5. Control incubation time with technetium as it affects colloid stability.

⚠️ Note: Tc-99m Nanocolloid is example of drug where physical parameter (size) is more important than chemical composition. Error in particle size makes drug completely useless or even dangerous for patient, so this checker is key QC tool for lymphoscintigraphy.