Lutetium177DOTATATEQualityChecker

Lutetium177 DOTATATE

decay correction endotoxins heavy metals impurities medical gases microbiology PET radionuclide purity

Lutetium-177 DOTATATE Quality Checker — Lutetium-177 DOTATATE solution (Lutathera®) (Ph. Eur., USP <823>, EMA)

ℹ️  The utility checks specific activity, radiochemical purity, impurities (177ᵐLu, free peptide), endotoxins, sterility, pH, heavy metals, residual solvents.
ℹ️  Does not use machine learning — rule-based logic only.
⚠️  CRITICAL: 177ᵐLu impurity (≤0.1%) — reduces therapeutic efficacy! Endotoxins (≤175 EU/vial) — pyrogenic reaction risk! Sterility — mandatory for parenteral forms!

Usage:
  Lutetium177DOTATATEQualityChecker.exe                            → demo mode (console output)
  Lutetium177DOTATATEQualityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,SpecificActivityGBqPerUmol,RadiochemicalPurityPercent,Impurity177mLuPercent,FreePeptidePercent,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,pH,EthanolPPM,AcetonePPM

Example (sterility: 0=sterile, 1=contaminated):
Lu177-DOTATATE-2026-001,30.0,99.0,0.05,3.0,100.0,0,5,6.0,800,500

— WHY IS THIS NEEDED?
Lutetium-177 DOTATATE solution (Lutathera®) — radiopharmaceutical for peptide receptor radionuclide therapy (PRRT):
• Treatment of neuroendocrine tumors (NET) with somatostatin receptor expression (gastroenteropancreatic NET)
• Intravenous administration with targeting to SSTR receptors on tumor cells
• Combined action: beta radiation (177Lu) + specific binding (DOTATATE)
⚠️ CRITICAL:
• Specific activity ≥25 GBq/μmol — ensures sufficient radiation dose to tumor with minimal peptide amount (avoids receptor saturation)
• Radiochemical purity ≥98.0% — guarantees radiation delivered specifically to tumor, not other organs
• 177ᵐLu impurity ≤0.1% — METASTABLE ISOMER with 160-day half-life! Reduces therapeutic efficacy and increases patient radiation burden
• Free peptide ≤5.0% — unbound DOTATATE competes for receptors, reducing therapy efficacy
• Endotoxins ≤175 EU/vial — critical for intravenous administration! Exceeding causes pyrogenic reactions
• Sterility — MANDATORY for all parenteral forms! Contamination = unfit for use
⚠️ Special attention: 177ᵐLu is a metastable isomer with 160-day half-life (vs 6.7 days for 177Lu). Even minor amount (0.1%) creates prolonged radiation burden on patient without therapeutic effect. Impurity control is critical! Endotoxins tested by LAL (limulus amebocyte lysate) method. Sterility — membrane filtration method (USP <71>).
Critical parameters:
• Specific activity: ≥25 GBq/μmol
• Radiochemical purity: ≥98.0%
• 177ᵐLu impurity: ≤0.1% (METASTABLE ISOMER!)
• Free peptide: ≤5.0%
• Endotoxins: ≤175 EU/vial (LAL test)
• Sterility: no microbial growth
• Heavy metals: ≤10 ppm
• pH: 4.5–7.5 (blood compatibility)
• Residual solvents: ethanol ≤5000 ppm, acetone ≤5000 ppm
⚠️ Note: Utility is designed for quality control of FINISHED INJECTABLE SOLUTION (not substance!). All parameters comply with parenteral form requirements. 177ᵐLu control performed by gamma spectrometry with peak resolution of 177Lu (208 keV) and 177ᵐLu (187 keV). Radiochemical purity determined by TLC or HPLC method.

input.csv

BatchNumber,SpecificActivityGBqPerUmol,RadiochemicalPurityPercent,Impurity177mLuPercent,FreePeptidePercent,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,pH,EthanolPPM,AcetonePPM
Lu177-DOTATATE-2026-001,30.0,99.0,0.05,3.0,100.0,0,5,6.0,800,500

URS & FS — user requirements and functional specification

This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.

Utility: Lutetium177DOTATATEQualityCheckerAPI / object: Lutetium177 DOTATATECategory: Radiopharmaceuticals

1. Scope

The Lutetium177 DOTATATE Quality Checker utility is used for Lutetium177 DOTATATE. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.

The utility does not use machine learning; decisions are produced by deterministic rules.

Categories: Radiopharmaceuticals

Tags: decay correction, endotoxins, heavy metals, impurities, medical gases, microbiology, PET, radionuclide purity, radiopharma, residual solvents, SPECT, sterility

2. Execution modes

Lutetium177DOTATATEQualityChecker.exe                            → demo mode (console output)
Lutetium177DOTATATEQualityChecker.exe input.csv output.json      → evaluate your data

3. Key controlled areas

purity and impurities
residual solvents
microbiology and pathogens
heavy metals / elemental impurities
pH and physicochemical parameters
activity, decay and radiochemical purity

4. Domain limits and critical parameters

⚠️ CRITICAL: 177ᵐLu impurity (≤0.1%) — reduces therapeutic efficacy! Endotoxins (≤175 EU/vial) — pyrogenic reaction risk! Sterility — mandatory for parenteral forms!
⚠️ CRITICAL:
Specific activity ≥25 GBq/μmol — ensures sufficient radiation dose to tumor with minimal peptide amount (avoids receptor saturation)
Radiochemical purity ≥98.0% — guarantees radiation delivered specifically to tumor, not other organs
177ᵐLu impurity ≤0.1% — METASTABLE ISOMER with 160-day half-life! Reduces therapeutic efficacy and increases patient radiation burden
Free peptide ≤5.0% — unbound DOTATATE competes for receptors, reducing therapy efficacy
Endotoxins ≤175 EU/vial — critical for intravenous administration! Exceeding causes pyrogenic reactions
Sterility — MANDATORY for all parenteral forms! Contamination = unfit for use
⚠️ Special attention: 177ᵐLu is a metastable isomer with 160-day half-life (vs 6.7 days for 177Lu). Even minor amount (0.1%) creates prolonged radiation burden on patient without therapeutic effect. Impurity control is critical! Endotoxins tested by LAL (limulus amebocyte lysate) method. Sterility — membrane filtration method (USP <71>).
Critical parameters:
Specific activity: ≥25 GBq/μmol
Radiochemical purity: ≥98.0%
177ᵐLu impurity: ≤0.1% (METASTABLE ISOMER!)
Free peptide: ≤5.0%
Endotoxins: ≤175 EU/vial (LAL test)
Sterility: no microbial growth
Heavy metals: ≤10 ppm
pH: 4.5–7.5 (blood compatibility)
Residual solvents: ethanol ≤5000 ppm, acetone ≤5000 ppm
⚠️ Note: Utility is designed for quality control of FINISHED INJECTABLE SOLUTION (not substance!). All parameters comply with parenteral form requirements. 177ᵐLu control performed by gamma spectrometry with peak resolution of 177Lu (208 keV) and 177ᵐLu (187 keV). Radiochemical purity determined by TLC or HPLC method.

Limits stated in the description must be verified against the current approved specification, pharmacopoeial monograph and registration dossier before production use.

5. URS — user requirements

ID	Requirement	Criticality	Acceptance criterion
URS-001	The system shall accept an `input.csv` file for Lutetium177 DOTATATE with the exact columns listed in the “Input data contract” section.	High	A file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error.
URS-002	The system shall support execution without arguments in demo mode and execution with `input.csv output.json` for user data.	Medium	Both execution scenarios produce a predictable result or clear diagnostic error.
URS-003	The system shall perform rule-based controls for: purity and impurities, residual solvents, microbiology and pathogens, heavy metals / elemental impurities, pH and physicochemical parameters, activity, decay and radiochemical purity.	High	Each controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML.
URS-004	The system shall preserve traceability between batch/lot, source values, applied rules and final verdict.	High	Output includes batch identifier, source values, parameter statuses and critical findings.
URS-005	The system shall generate machine-readable `output.json` for LIMS/ELN/MES, batch record and QA/QC review.	High	JSON contains overall status, check array, warnings, failures and source-file reference.
URS-006	The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks.	High	The document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval.
URS-007	The system shall clearly separate technical data errors from specification nonconformities.	Medium	Schema/type errors are not mixed with pharmacopoeial deviations and are reported separately.

6. input.csv data contract

The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.

#	Column	Type	Unit	Description	Sample	Control rule
1	`BatchNumber`	identifier	as specified	Batch Number	`Lu177-DOTATATE-2026-001`	mandatory field; used for batch/lot traceability
2	`SpecificActivityGBqPerUmol`	decimal	GBq	Specific Activity GBq per Umol	`30.0`	mandatory numeric value; rule comparison is performed by the utility
3	`RadiochemicalPurityPercent`	decimal	%	Radiochemical Purity %	`99.0`	numeric value; compared with assay/purity limit from specification or method
4	`Impurity177mLuPercent`	decimal	%	Impurity177m Lu %	`0.05`	numeric value; compared with individual or total impurity limit
5	`FreePeptidePercent`	decimal	%	Free Peptide %	`3.0`	mandatory numeric value; rule comparison is performed by the utility
6	`EndotoxinsEU`	decimal	as specified	Endotoxins EU	`100.0`	numeric value; critical safety attribute compared with endotoxin limit
7	`SterilityTest`	boolean / flag	0/1	Sterility Test	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent
8	`HeavyMetalsPPM`	decimal	ppm	Heavy Metals PPM	`5`	numeric value; checked as elemental/metal impurity
9	`pH`	decimal	pH	p H	`6.0`	mandatory numeric value; rule comparison is performed by the utility
10	`EthanolPPM`	decimal	ppm	Ethanol PPM	`800`	numeric value; checked as residual solvent against the applicable limit
11	`AcetonePPM`	decimal	ppm	Acetone PPM	`500`	numeric value; checked as residual solvent against the applicable limit

CSV example

BatchNumber,SpecificActivityGBqPerUmol,RadiochemicalPurityPercent,Impurity177mLuPercent,FreePeptidePercent,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,pH,EthanolPPM,AcetonePPM
Lu177-DOTATATE-2026-001,30.0,99.0,0.05,3.0,100.0,0,5,6.0,800,500

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `Lutetium177DOTATATEQualityChecker.exe` supports demo mode and `input.csv output.json` processing mode.
FS-002	CSV parser	The import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator.
FS-003	Field conversion	Each column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag.
FS-004	Domain rule engine	For Lutetium177 DOTATATE, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check.
FS-005	Criticality handling	Critical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS.
FS-006	JSON writer	`output.json` stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages.
FS-007	Integration contract	The CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service.
FS-008	Error handling	Schema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS.

8. output.json contract

The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.

{
  "utility": "Lutetium177DOTATATEQualityChecker",
  "api": "Lutetium177 DOTATATE",
  "batchNumber": "Lu177-DOTATATE-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "Lu177-DOTATATE-2026-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SpecificActivityGBqPerUmol",
      "value": "30.0",
      "unit": "GBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "99.0",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Impurity177mLuPercent",
      "value": "0.05",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreePeptidePercent",
      "value": "3.0",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "100.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SterilityTest",
      "value": "0",
      "unit": "0/1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "HeavyMetalsPPM",
      "value": "5",
      "unit": "ppm",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "sourceFile": "input.csv"
}

9. OQ/PQ test scenarios

ID	Scenario	Expected result
TC-001	Valid CSV with expected header and sample row	All rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail.
TC-002	A mandatory input.csv column is missing	Import is rejected or the row receives FAIL with schema reference.
TC-003	A numeric field contains text or a blank value	Type conversion error is recorded; the result is not hidden as PASS.
TC-004	A parameter is outside specification or critical limit	Critical parameters produce FAIL; non-critical deviations produce WARNING according to the rule.
TC-005	Positive pathogen/microbiological flag or microbiological limit excursion	Critical FAIL is produced with the offending parameter.
TC-007	Residual solvent above applicable limit	FAIL is produced with solvent name and measured value.
TC-008	Incorrect activity, reference time or radiochemical purity	FAIL/WARNING is produced with calculation traceability.

10. QA/QC, CSV and change control

Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
Column names must not be changed without updating the validator and test scenarios.
The source CSV, output.json and utility version should be stored together as an evidence package.
Any change in control rules must go through change control and repeated OQ scenario verification.

Included in packages

Endocrinology QC Suite

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

Open

Gastroenterology QC Suite

QC package for gastroenterology: PPIs, antiemetics, prokinetics, IBD medicines, laxatives, enzymes and GI anti-infectives.

Open

Neurology QC Suite

QC package for neurology and neuropsychiatry: antiepileptics, antiparkinsonian medicines, antidepressants, antipsychotics, analgesics and neurological diagnostic radiopharmaceuticals.

Open

PetRad QC Suite

A specialised utility package for radiopharmaceutical quality control: PET, SPECT, therapeutic radionuclides, generators and decay calculations.

Open

Radiology QC Suite

QC package for radiology and diagnostic imaging: radiopharmaceuticals, PET/SPECT, contrast media, iodinated and gadolinium products, plus particle, sterility and endotoxin checks.

Open

RPH isotope family: beta-emitting therapy

Lu-177, Y-90, Ho-166, Re-188, Sm-153, Sr-89, P-32, Cu-67 and Tb-161.

Open

RPH organ/system: brain and CNS

Brain perfusion, dopamine transporter, amyloid/tau, receptor imaging and neurological SPECT/PET.

Open

RPH organ/system: endocrine, thyroid and NET

Radioiodine, thyroid/parathyroid, somatostatin receptor, MIBG and neuroendocrine workflows.

Open

RPH organ/system: hepatobiliary and GI

HIDA, mebrofenin, gallbladder, gastric emptying, GI transit, bleeding and liver/spleen imaging.

Open

RPH organ/system: oncology and theranostics

Tumour imaging, PSMA/FAPI/receptor tracers, immuno-PET, targeted radionuclide therapy and radioembolization.

Open

RPH use case: radionuclide therapy and theranostics

Lu-177, Ac-225, Ra-223, Y-90, Ho-166, Sm-153, Sr-89, Re-188, Tb-161, I-131 and other therapeutic radiopharmaceuticals: activity, purity, free metal, daughters and toxicological constraints.

Open

RPH workflow: product release QC

Assay, purity, sterility, endotoxins, pH, impurities, appearance and batch-release checks.

Open

RPH workflow: stability, storage, decay and waste

Kinetic stability, shelf life, decay correction, expiry, storage, trend and radioactive waste.

Open

RPH: combined radiopharmaceutical QC package

RPH combines PetRad, PetRad2 and PetRad3 into one umbrella package for PET/SPECT, therapeutic radionuclides, generators, labelled compounds, decay calculations, sterility, endotoxins and radiochemical/radionuclidic purity.

Open