Lu177DOTATATETherapyQualityChecker

Lu-177 DOTATATE Therapy Quality Checker

api radiopharmaceuticals nuclear-medicine lu-177 prrt theranostics neuroendocrine-tumours

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Lu-177 DOTATATE Therapy Quality Checker — Quality control of Lu-177 DOTATATE for PRRT

ℹ️ Utility checks critical parameters of Lu-177 DOTATATE:

Radiochemical purity (≥95%)
Free lutetium (≤2%)
Precursor residue (<0.1%)
Specific activity (≥20 GBq/mg)
Lu-177m impurity (<0.01%) — CRITICAL!

⚠️ CRITICAL: Lu-177m (T½=160 days) creates long-term radiation burden!

Lu-177 DOTATATE is used for PRRT (neuroendocrine tumor therapy).

High specific activity is necessary for effective receptor binding.

Usage

Lu177DOTATATETherapyQualityChecker.exe → demo mode (console output)

Lu177DOTATATETherapyQualityChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,FreeLutetiumPercent,PrecursorPercent,SpecificActivityGBq_per_mg,pH,ResidualSolventsPPM,EndotoxinsEU_per_mL,SterilityTest,ActivityGBq,RadionuclidicPurityPercent,Lu177mImpurityPercent

Example

LU177-DOTATATE-THER-2026-001,99.0,0.5,0.05,40.0,5.0,100.0,10.0,0,7.4,99.99,0.0005

— WHY IS THIS NEEDED?

Lu-177 DOTATATE (Lutathera) is standard therapy for neuroendocrine tumors (NETs).

Binds to somatostatin receptors (SSTR2).
Lu-177 emits beta particles for therapy and gamma quanta for imaging.
Half-life 6.65 days.
Requires high radiochemical purity and specific activity.

⚠️ CRITICAL:

Radiochemical purity ≥95% — guarantee of dose delivery to tumor.
Free lutetium ≤2% — free ions accumulate in bones and liver.
Precursor residue <0.1% — unreacted peptide competes for receptors.
Specific activity ≥20 GBq/mg — necessary for high contrast and efficacy.
Lu-177m impurity <0.01% — Lu-177m is long-lived and creates unnecessary radiation burden.
pH 4.5-6.5 — optimal media for Lu-DOTA complex stability.
Residual solvents must be minimal (<500 ppm).
Endotoxins <175 EU/mL — standard for parenteral drugs.
Sterility — MANDATORY.

Key features

Strict control of Lu-177m impurity characteristic of reactor production.
Assessment of residual precursor, critical for therapy efficacy.
Specific activity check for effective targeting.
Compliance with GMP and Pharmacopoeia requirements for Lu-177 radiopharmaceuticals.
Comprehensive safety check (endotoxins, sterility, pH, solvents).

Critical parameters

Radiochemical purity: ≥95.0%
Free lutetium: ≤2.0%
Precursor residue: <0.1%
Specific activity: ≥20.0 GBq/mg
Radionuclidic purity: ≥99.9%
Lu-177m impurity: <0.01%
Residual solvents: <500 ppm
pH: 4.5–6.5
Endotoxins: <175 EU/mL
Sterility: no growth

💡 Usage tips:

1. Radiochemical purity determined by TLC or HPLC.

2. Lu-177m impurity controlled by gamma spectrometry.

3. Synthesis usually performed on automatic modules or manually using kits.

4. Drug is stable for several days due to strong DOTA complex.

5. Lu-177 emits gamma quanta 208 and 113 keV, allowing post-therapeutic imaging.

⚠️ Note: Lu-177 DOTATATE represents successful theranostics example (therapy + diagnostics). Quality control here is critical as error in dosing or purity can lead either to treatment inefficacy or serious toxicity to kidneys and bone marrow.

input.csv

BatchNumber,RadiochemicalPurityPercent,FreeLutetiumPercent,PrecursorPercent,SpecificActivityGBq_per_mg,pH,ResidualSolventsPPM,EndotoxinsEU_per_mL,SterilityTest,ActivityGBq,RadionuclidicPurityPercent,Lu177mImpurityPercent
LU177-DOTATATE-THER-2026-001,99.0,0.5,0.05,40.0,5.0,100.0,10.0,0,7.4,99.99,0.0005
LU177-DOTATATE-THER-2026-002,97.0,1.5,0.08,35.0,4.8,200.0,20.0,0,7.0,99.95,0.0008
LU177-DOTATATE-THER-2026-003,90.0,5.0,0.2,25.0,6.0,600.0,50.0,1,6.5,99.50,0.0020

URS & FS — user requirements and functional specification

URS — User Requirements Specification

The utility shall accept input.csv with these mandatory columns: BatchNumber, RadiochemicalPurityPercent, FreeLutetiumPercent, PrecursorPercent, SpecificActivityGBq_per_mg, pH, ResidualSolventsPPM, EndotoxinsEU_per_mL, SterilityTest, ActivityGBq, RadionuclidicPurityPercent, Lu177mImpurityPercent.
Each row shall be processed as a separate batch or record identified by BatchNumber.
Before evaluation, the utility shall validate the CSV structure, mandatory values, numeric fields and allowed text values.
Rules and limits shall be applied to every parameter in the input row.
Critical violations identified in the supplied description shall set the record result to FAIL.
Each row shall receive an overall PASS, WARNING or FAIL status with the triggered rules.
An invalid row shall not receive PASS.
output.json shall contain source values, applied limits, individual check results and errors.
The same input and the same rule profile shall produce the same result.

FS — Functional Specification

Run Lu177DOTATATETherapyQualityChecker.exe in demonstration mode or with input.csv output.json arguments.
Read UTF-8 CSV and verify the exact set of mandatory columns.
Convert row values to numeric and text types.
Apply the rules defined in the approved version or configuration profile.
Generate individual check results and derive the overall status from the most severe violation.
Write machine-readable output.json.
Structural and type errors shall be reported explicitly and shall not be masked by a successful status.

Complete input.csv example

BatchNumber,RadiochemicalPurityPercent,FreeLutetiumPercent,PrecursorPercent,SpecificActivityGBq_per_mg,pH,ResidualSolventsPPM,EndotoxinsEU_per_mL,SterilityTest,ActivityGBq,RadionuclidicPurityPercent,Lu177mImpurityPercent
LU177-DOTATATE-THER-2026-001,99.0,0.5,0.05,40.0,5.0,100.0,10.0,0,7.4,99.99,0.0005
LU177-DOTATATE-THER-2026-002,97.0,1.5,0.08,35.0,4.8,200.0,20.0,0,7.0,99.95,0.0008
LU177-DOTATATE-THER-2026-003,90.0,5.0,0.2,25.0,6.0,600.0,50.0,1,6.5,99.50,0.0020

Purpose of the supplied test rows

The first row contains values consistent with the criteria stated in the supplied description.
The second row contains values closer to the limits or moderate deviations.
The third row contains clear deviations for negative-result testing.

Minimum output.json structure

{
  "utility": "Lu177DOTATATETherapyQualityChecker",
  "source": "input.csv",
  "results": [
    {
      "batchNumber": "BATCH-001",
      "status": "PASS",
      "checks": [
        {
          "parameter": "ParameterName",
          "value": 0,
          "limit": "configured rule",
          "status": "PASS"
        }
      ],
      "errors": []
    }
  ]
}

Minimum OQ scenarios

Process the complete supplied input.csv.
Remove a mandatory column and confirm a contract error.
Provide text instead of a numeric value and confirm a type error.
Test values directly on the configured limits.
Repeat the run with the same input and confirm an identical result.

Before operational use

Reconcile rules and limits with the approved specification, methods and SOP.
Fix the executable version and rule-profile version.
Retain the source CSV together with the generated JSON.

Included in packages

Endocrinology QC Suite

QC package for endocrinology: thyroid, pituitary/peptide hormones, corticosteroids, sex hormones and selected metabolic medicines.

Lu177DOTATATETherapyQualityChecker