Radium223DichlorideQualityChecker

Radium223 Dichloride

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

Radium-223 Dichloride Quality Checker — Radium-223 dichloride solution (Xofigo®) (Ph. Eur., USP <823>, FDA)

ℹ️ The utility checks activity, radiochemical purity, radon-222 impurity, pH, chlorides, endotoxins, sterility, heavy metals, residual solvents.
ℹ️ Does not use machine learning — rule-based logic only.
⚠️ CRITICAL: Radon-222 (≤10 Bq/mL) — GASEOUS decay product! Container integrity control is mandatory! Endotoxins (≤175 EU/vial) and sterility — mandatory for parenteral forms!

Usage:
Radium223DichlorideQualityChecker.exe → demo mode (console output)
Radium223DichlorideQualityChecker.exe input.csv output.json → evaluate your data

Input format:
BatchNumber,ActivityMBqPerMl,RadiochemicalPurityPercent,Radon222ImpurityBqPerMl,pH,ChloridesMgPerMl,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,EthanolPPM,AcetonePPM

Example (sterility: 0=sterile, 1=contaminated):
Ra223-2026-001,1.10,98.0,5.0,5.0,8.0,120.0,0,5,800,500

— WHY IS THIS NEEDED?
Radium-223 dichloride solution (Xofigo®) — radiopharmaceutical for treatment of metastatic castration-resistant prostate cancer with bone metastases:
• Alpha emitter with 11.4-day half-life
• Calcium mimicry — selectively accumulates in bone metastases
• Intravenous administration delivering high local radiation dose to tumor sites
⚠️ CRITICAL:
• Activity 1.1 MBq/mL ±10% — ensures accurate dosing (50–55 kBq/kg body weight) for effective bone metastasis therapy
• Radiochemical purity ≥95.0% — guarantees delivery of alpha radiation specifically to bone metastases, not other organs
• Radon-222 ≤10 Bq/mL — CRITICAL! Radon-222 is a GASEOUS decay product of radium-223 (3.8-day half-life). Radon leakage creates radiation hazard for personnel and patients! Container integrity control is mandatory!
• pH 4.0–6.0 — critical for blood compatibility during intravenous administration
• Endotoxins ≤175 EU/vial — critical for intravenous administration! Exceeding causes pyrogenic reactions
• Sterility — MANDATORY for all parenteral forms! Contamination = unfit for use
⚠️ Special attention: Radon-222 is a noble gas that easily penetrates through micro-defects in packaging. Container integrity control must be performed using special radon detectors. Even minor leakage (10 Bq/mL) creates radiation hazard in enclosed spaces. Endotoxins tested by LAL method. Sterility — membrane filtration method (USP <71>).
Critical parameters:
• Activity: 1.1 MBq/mL ±10% (0.99–1.21 MBq/mL)
• Radiochemical purity: ≥95.0%
• Radon-222: ≤10 Bq/mL (GASEOUS DECAY PRODUCT!)
• pH: 4.0–6.0 (blood compatibility)
• Chlorides: ≤10 mg/mL
• Endotoxins: ≤175 EU/vial (LAL test)
• Sterility: no microbial growth
• Heavy metals: ≤10 ppm
• Residual solvents: ethanol ≤5000 ppm, acetone ≤5000 ppm
⚠️ Note: Utility is designed for quality control of FINISHED INJECTABLE SOLUTION. All parameters comply with parenteral form requirements for metastatic prostate cancer therapy. Radon-222 control performed using alpha spectrometry or ionization chambers. Radiochemical purity determined by TLC or HPLC with radiodetection. Activity measured using calibrated ionization chamber.

input.csv

BatchNumber,ActivityMBqPerMl,RadiochemicalPurityPercent,Radon222ImpurityBqPerMl,pH,ChloridesMgPerMl,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,EthanolPPM,AcetonePPM
Ra223-2026-001,1.10,98.0,5.0,5.0,8.0,120.0,0,5,800,500

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: Radium223DichlorideQualityCheckerAPI / object: Radium223 DichlorideCategory: Radiopharmaceuticals

1. Scope

The Radium223 Dichloride Quality Checker utility is used for Radium223 Dichloride. 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

Radium223DichlorideQualityChecker.exe                            → demo mode (console output)
Radium223DichlorideQualityChecker.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: Radon-222 (≤10 Bq/mL) — GASEOUS decay product! Container integrity control is mandatory! Endotoxins (≤175 EU/vial) and sterility — mandatory for parenteral forms!
⚠️ CRITICAL:
Activity 1.1 MBq/mL ±10% — ensures accurate dosing (50–55 kBq/kg body weight) for effective bone metastasis therapy
Radiochemical purity ≥95.0% — guarantees delivery of alpha radiation specifically to bone metastases, not other organs
Radon-222 ≤10 Bq/mL — CRITICAL! Radon-222 is a GASEOUS decay product of radium-223 (3.8-day half-life). Radon leakage creates radiation hazard for personnel and patients! Container integrity control is mandatory!
pH 4.0–6.0 — critical for blood compatibility during intravenous administration
Endotoxins ≤175 EU/vial — critical for intravenous administration! Exceeding causes pyrogenic reactions
Sterility — MANDATORY for all parenteral forms! Contamination = unfit for use
⚠️ Special attention: Radon-222 is a noble gas that easily penetrates through micro-defects in packaging. Container integrity control must be performed using special radon detectors. Even minor leakage (10 Bq/mL) creates radiation hazard in enclosed spaces. Endotoxins tested by LAL method. Sterility — membrane filtration method (USP <71>).
Critical parameters:
Activity: 1.1 MBq/mL ±10% (0.99–1.21 MBq/mL)
Radiochemical purity: ≥95.0%
Radon-222: ≤10 Bq/mL (GASEOUS DECAY PRODUCT!)
pH: 4.0–6.0 (blood compatibility)
Chlorides: ≤10 mg/mL
Endotoxins: ≤175 EU/vial (LAL test)
Sterility: no microbial growth
Heavy metals: ≤10 ppm
Residual solvents: ethanol ≤5000 ppm, acetone ≤5000 ppm
⚠️ Note: Utility is designed for quality control of FINISHED INJECTABLE SOLUTION. All parameters comply with parenteral form requirements for metastatic prostate cancer therapy. Radon-222 control performed using alpha spectrometry or ionization chambers. Radiochemical purity determined by TLC or HPLC with radiodetection. Activity measured using calibrated ionization chamber.

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 Radium223 Dichloride 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	`Ra223-2026-001`	mandatory field; used for batch/lot traceability
2	`ActivityMBqPerMl`	decimal	MBq	Activity MBq per Ml	`1.10`	mandatory numeric value; rule comparison is performed by the utility
3	`RadiochemicalPurityPercent`	decimal	%	Radiochemical Purity %	`98.0`	numeric value; compared with assay/purity limit from specification or method
4	`Radon222ImpurityBqPerMl`	decimal	as specified	Radon222 Impurity Bq per Ml	`5.0`	numeric value; compared with individual or total impurity limit
5	`pH`	decimal	pH	p H	`5.0`	mandatory numeric value; rule comparison is performed by the utility
6	`ChloridesMgPerMl`	decimal	mg/ml	Chlorides Mg per Ml	`8.0`	mandatory numeric value; rule comparison is performed by the utility
7	`EndotoxinsEU`	decimal	as specified	Endotoxins EU	`120.0`	numeric value; critical safety attribute compared with endotoxin limit
8	`SterilityTest`	boolean / flag	0/1	Sterility Test	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent
9	`HeavyMetalsPPM`	decimal	ppm	Heavy Metals PPM	`5`	numeric value; checked as elemental/metal impurity
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,ActivityMBqPerMl,RadiochemicalPurityPercent,Radon222ImpurityBqPerMl,pH,ChloridesMgPerMl,EndotoxinsEU,SterilityTest,HeavyMetalsPPM,EthanolPPM,AcetonePPM
Ra223-2026-001,1.10,98.0,5.0,5.0,8.0,120.0,0,5,800,500

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `Radium223DichlorideQualityChecker.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 Radium223 Dichloride, 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": "Radium223DichlorideQualityChecker",
  "api": "Radium223 Dichloride",
  "batchNumber": "Ra223-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "Ra223-2026-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ActivityMBqPerMl",
      "value": "1.10",
      "unit": "MBq",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "98.0",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Radon222ImpurityBqPerMl",
      "value": "5.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "5.0",
      "unit": "pH",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ChloridesMgPerMl",
      "value": "8.0",
      "unit": "mg/ml",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "120.0",
      "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"
    }
  ],
  "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.

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