In111OctreotideQualityChecker

In-111 Octreotide Quality Checker

api radiopharmaceuticals nuclear-medicine in-111 spect somatostatin-receptor neuroendocrine-tumours

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In-111 Octreotide Quality Checker — Quality control of In-111 Octreotide

ℹ️ Utility checks critical parameters of In-111 Octreotide:

Radiochemical purity (≥95%)
Free and colloidal In-111 (≤5% and <2%)
Specific activity (≥20 MBq/mg)
pH, endotoxins, sterility

⚠️ CRITICAL: Free indium accumulates in liver, masking metastases!

In-111 Octreotide is used for SPECT imaging of NETs.

In-DOTA complex is very stable but requires correct pH.

Usage

In111OctreotideQualityChecker.exe → demo mode (console output)

In111OctreotideQualityChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,FreeIndiumPercent,ColloidalIndiumPercent,SpecificActivityMBq_per_mg,pH,ResidualSolventsPPM,EndotoxinsEU_per_mL,SterilityTest,ActivityMBq,RadionuclidicPurityPercent,Cd111ImpurityPercent

Example

IN111-OCT-2026-001,98.0,1.5,0.5,40.0,5.0,100.0,10.0,0,200.0,99.95,0.0

— WHY IS THIS NEEDED?

In-111 Octreotide (Octreoscan) is classic drug for SPECT diagnosis of neuroendocrine tumors.

Binds to somatostatin receptor subtypes (SSTR2).
In-111 has 2.8-day half-life, convenient for delayed imaging (24-48 h).
Requires high radiochemical purity for specific accumulation.
DOTA chelator ensures high stability of In-111 complex.

⚠️ CRITICAL:

Radiochemical purity ≥95% — guarantee of specific binding to SSTR.
Free In-111 ≤5% — free ions accumulate in liver and bones.
Colloidal In-111 <2% — colloids are taken up by liver and spleen macrophages.
Specific activity must be high for effective targeting.
pH 4.0-6.0 — optimal media for In-DOTA complex stability.
Residual solvents must be minimal (<500 ppm).
Endotoxins <175 EU/mL — standard for parenteral drugs.
Sterility — MANDATORY.

Key features

Separate accounting of free and colloidal indium.
Specific activity assessment for effective receptor binding.
pH check as complex stability factor.
Compliance with GMP and Pharmacopoeia requirements for In-111 radiopharmaceuticals.
Comprehensive safety check (endotoxins, sterility, pH, solvents).

Critical parameters

Radiochemical purity: ≥95.0%
Free In-111: ≤5.0%
Colloidal In-111: <2.0%
Specific activity: ≥20.0 MBq/mg
Radionuclidic purity: ≥99.9%
Residual solvents: <500 ppm
pH: 4.0–6.0
Endotoxins: <175 EU/mL
Sterility: no growth

💡 Usage tips:

1. Radiochemical purity determined by TLC or HPLC.

2. Synthesis usually performed by incubating In-111 chloride with octreotide at elevated temperature.

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

4. Delayed imaging (after 24-48 hours) allows reducing background in liver and intestines.

5. In-111 emits gamma quanta 171 and 245 keV, optimal for SPECT cameras.

⚠️ Note: Despite emergence of Ga-68 analogs for PET, In-111 Octreotide remains important tool, especially in centers without PET/CT. Its long half-life allows delayed studies, which sometimes improves contrast due to clearance of unbound drug.

input.csv

BatchNumber,RadiochemicalPurityPercent,FreeIndiumPercent,ColloidalIndiumPercent,SpecificActivityMBq_per_mg,pH,ResidualSolventsPPM,EndotoxinsEU_per_mL,SterilityTest,ActivityMBq,RadionuclidicPurityPercent,Cd111ImpurityPercent
IN111-OCT-2026-001,98.0,1.5,0.5,40.0,5.0,100.0,10.0,0,200.0,99.95,0.0
IN111-OCT-2026-002,96.0,3.0,1.0,35.0,4.5,200.0,20.0,0,180.0,99.90,0.0
IN111-OCT-2026-003,90.0,8.0,3.0,25.0,6.5,600.0,50.0,1,150.0,99.50,0.0

URS & FS — user requirements and functional specification

URS — User Requirements Specification

The utility shall accept input.csv with these mandatory columns: BatchNumber, RadiochemicalPurityPercent, FreeIndiumPercent, ColloidalIndiumPercent, SpecificActivityMBq_per_mg, pH, ResidualSolventsPPM, EndotoxinsEU_per_mL, SterilityTest, ActivityMBq, RadionuclidicPurityPercent, Cd111ImpurityPercent.
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 In111OctreotideQualityChecker.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,FreeIndiumPercent,ColloidalIndiumPercent,SpecificActivityMBq_per_mg,pH,ResidualSolventsPPM,EndotoxinsEU_per_mL,SterilityTest,ActivityMBq,RadionuclidicPurityPercent,Cd111ImpurityPercent
IN111-OCT-2026-001,98.0,1.5,0.5,40.0,5.0,100.0,10.0,0,200.0,99.95,0.0
IN111-OCT-2026-002,96.0,3.0,1.0,35.0,4.5,200.0,20.0,0,180.0,99.90,0.0
IN111-OCT-2026-003,90.0,8.0,3.0,25.0,6.5,600.0,50.0,1,150.0,99.50,0.0

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": "In111OctreotideQualityChecker",
  "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.

In111OctreotideQualityChecker