Tc99mSestamibiQualityChecker

Tc-99m Sestamibi

radiopharmaceuticals QC URS & FS input.csv output.json radiochemical purity radionuclidic purity SPECT

Utility description: Tc-99m Sestamibi

Tc-99m Sestamibi Quality Checker — Technetium-99m Sestamibi (MIBI) for Cardiology and Surgery

ℹ️ Utility checks critical parameters of Tc-99m Sestamibi:
• Radiochemical purity (≥90%)
• Free pertechnetate (≤5%)
• Colloidal technetium (≤5%)
• Boiling time control (10 min) — CRITICAL!
• pH (5.0–6.5), endotoxins, sterility

⚠️ CRITICAL: Insufficient boiling time (<10 min) leads to low labeling yield.
High liver uptake (due to impurities) interferes with assessment of the inferior myocardial wall.

Usage:
Tc99mSestamibiQualityChecker.exe → demo mode (console output)
Tc99mSestamibiQualityChecker.exe input.csv output.json → evaluate your data

Input format:
BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,ReactionTimeMin,CoolingTimeMin,ProductType

Example (sterility: 0=sterile, 1=contaminated):
TC99M-MIBI-2026-045,925.0,96.0,2.5,1.5,5.5,12.0,0,10.0,15.0,Cardiac

Supported product types:
• Cardiac — myocardial perfusion (ischemia, infarction)
• Parathyroid — imaging of parathyroid adenomas

— WHY IS THIS NEEDED?
Tc-99m Sestamibi (Methoxyisobutylisonitrile, MIBI) is a lipophilic cationic complex:
• Accumulates in cell mitochondria due to negative membrane potential
• Cardiology: Gold standard for SPECT myocardial perfusion. Allows distinguishing ischemia from scar.
• Surgery: Used for localization of parathyroid adenomas (parathyroidectomy).
• Excreted via hepatobiliary system, requiring high drug quality to minimize liver background.

⚠️ CRITICAL:
• Radiochemical purity ≥90% — Low RCP leads to free pertechnetate (stomach/thyroid background) and colloid (liver background). For cardiology, liver accumulation is particularly critical because the right coronary artery supplies the inferior wall of the left ventricle, which is anatomically adjacent to the liver. Liver background can mimic a perfusion defect.
• Preparation Process (Boiling) — MIBI kit REQUIRES boiling for 10 minutes to complete ligand exchange reaction. Without this, labeled product yield will be low.
• Free pertechnetate ≤5% — Creates artifacts.
• Reduced/Hydrolyzed Tc ≤5% — Accumulates in liver.
• pH 5.0–6.5 — Specific range for MIBI complex stability.
• Endotoxins ≤175 EU/vial, Sterility — standard requirements.

Key features:
• Control of preparation parameter (boiling time)
• Assessment of suitability for cardiac and surgical diagnosis
• Separation of major radiochemical impurities

Critical parameters:
• Radiochemical purity: ≥90.0%
• Free pertechnetate: ≤5.0%
• Colloidal Tc: ≤5.0%
• Boiling time: 10–15 minutes (STRICT!)
• pH: 5.0–6.5
• Endotoxins: ≤175 EU/vial
• Sterility: no microbial growth

💡 Usage tips:
1. To determine RCP, TLC is used:
- System 1 (Acetone): Separates free pertechnetate (moves) from complex and colloid (origin).
- System 2 (Ethanol/Ammonia etc.): Separates hydrophilic impurities.
2. Strictly observe boiling time. Use water bath.
3. After boiling, allow vial to cool to room temperature (about 15-30 min) before administration.
4. MIBI is stable for 4-6 hours after preparation.

⚠️ Note: In cardiology, drug quality directly affects diagnostic accuracy. "Hot" liver due to impurities is a frequent cause of false-positive diagnoses of inferior wall ischemia.

input.csv

BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,ReactionTimeMin,CoolingTimeMin,ProductType
TC99M-MIBI-2026-045,925.0,96.0,2.5,1.5,5.5,12.0,0,10.0,15.0,Cardiac
TC99M-MIBI-FAIL-046,900.0,85.0,10.0,5.0,5.8,20.0,0,8.0,10.0,Cardiac
TC99M-MIBI-PARA-047,370.0,94.0,3.0,3.0,5.2,10.0,0,10.0,20.0,Parathyroid

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Tc99mSestamibiQualityChecker for Tc-99m Sestamibi.

Domain limits and critical parameters

Key fragments from the source description are shown below. Before production use, limits must be verified against the approved specification, registration dossier and local SOPs.

ℹ️ Utility checks critical parameters of Tc-99m Sestamibi:
• Radiochemical purity (≥90%)
• Free pertechnetate (≤5%)
• Colloidal technetium (≤5%)
• Boiling time control (10 min) — CRITICAL!
• pH (5.0–6.5), endotoxins, sterility
⚠️ CRITICAL: Insufficient boiling time (<10 min) leads to low labeling yield.
BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,ReactionTimeMin,CoolingTimeMin,ProductType
Example (sterility: 0=sterile, 1=contaminated):
⚠️ CRITICAL:
• Free pertechnetate ≤5% — Creates artifacts.
• Reduced/Hydrolyzed Tc ≤5% — Accumulates in liver.
• Endotoxins ≤175 EU/vial, Sterility — standard requirements.
Critical parameters:

URS — User Requirements Specification

ID	Requirement	Criticality	Acceptance criterion
URS-001	The utility shall accept an `input.csv` file with the exact headers defined in the data contract.	High	The file is processed without manual header editing.
URS-002	The utility shall perform deterministic QC evaluation for Tc-99m Sestamibi using input values, approved limits and domain rules.	High	Each input row receives a `PASS / WARNING / FAIL` status.
URS-003	The utility shall validate mandatory fields, data types, numeric ranges, units and pharmaceutical/radiochemical plausibility.	High	Schema and conversion errors are explicitly reported.
URS-004	The utility shall identify critical deviations related to radionuclidic purity, radiochemical purity, free radionuclide, impurities, pH, endotoxins and sterility when such fields are present.	High	A critical deviation causes FAIL or a separate critical finding.
URS-005	The utility shall generate `output.json` with machine-readable results, source values, warnings and failures.	High	JSON is suitable for LIMS/ELN/MES integration and QA/QC review.
URS-006	The utility shall not use machine learning to decide conformance.	Medium	The result is based on explicit rules, thresholds and input values.
URS-007	The utility shall preserve traceability between batch number, input values, applied rules and final status.	High	The output contains the batch identifier and the list of checked parameters.
URS-008	The documentation shall support IQ/OQ preparation and inspection discussion with FDA/EMA/Roszdravnadzor or local regulators.	Medium	URS & FS, `input.csv`/`output.json` contract and test scenarios are supplied with the utility.

input.csv contract

#	Field	Type	Sample	Purpose
1	`BatchNumber`	string	`TC99M-MIBI-2026-045`	Batch or lot identifier used for traceability.
2	`TotalActivityMBq`	decimal	`925.0`	Radioactivity value used for release, decay or dose-related assessment.
3	`RadiochemicalPurityPercent`	string	`96.0`	Radiochemical purity; confirms the labelled chemical form and binding quality.
4	`FreePertechnetatePercent`	decimal	`2.5`	Free radionuclide / unbound species; important for non-target uptake and toxicity.
5	`ReducedHydrolyzedTcPercent`	decimal	`1.5`	Controlled input parameter used by the deterministic QC rules.
6	`pH`	decimal	`5.5`	Solution pH; relevant for stability, compatibility and administration.
7	`EndotoxinsEU`	decimal	`12.0`	Bacterial endotoxins; critical for parenteral administration.
8	`SterilityTest`	flag / boolean	`0`	Sterility result; critical release parameter.
9	`ReactionTimeMin`	datetime / string	`10.0`	Time point used for decay, stability or ingrowth calculation.
10	`CoolingTimeMin`	datetime / string	`15.0`	Time point used for decay, stability or ingrowth calculation.
11	`ProductType`	string	`Cardiac`	Controlled input parameter used by the deterministic QC rules.

BatchNumber,TotalActivityMBq,RadiochemicalPurityPercent,FreePertechnetatePercent,ReducedHydrolyzedTcPercent,pH,EndotoxinsEU,SterilityTest,ReactionTimeMin,CoolingTimeMin,ProductType
TC99M-MIBI-2026-045,925.0,96.0,2.5,1.5,5.5,12.0,0,10.0,15.0,Cardiac
TC99M-MIBI-FAIL-046,900.0,85.0,10.0,5.0,5.8,20.0,0,8.0,10.0,Cardiac
TC99M-MIBI-PARA-047,370.0,94.0,3.0,3.0,5.2,10.0,0,10.0,20.0,Parathyroid

FS — Functional Specification

ID	Function	Implementation
FS-001	CSV import	Read `input.csv` in UTF-8/CSV-compatible format and validate the header and expected columns.
FS-002	Schema validation	Check mandatory fields and column count; report unknown or missing key fields.
FS-003	Type conversion	Convert numeric, flag and text values; invalid formats are recorded as row-level errors.
FS-004	Domain rule engine	Apply domain rules for Tc-99m Sestamibi, including critical limits from the utility description and approved specification.
FS-005	Status aggregation	Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance.
FS-006	JSON export	Write `output.json` with detailed checks, source values, warnings, failures and critical findings.
FS-007	Audit support	Keep the result structure suitable for review, deviation investigation, calculation reproduction and IQ/OQ preparation.
FS-008	Integration contract	Support the production scenario: LIMS/ELN/MES creates `input.csv`, the utility returns `output.json`, the portal displays description and documentation.

Example output.json

{
  "utilityId": "tc99m-sestamibi-quality-checker",
  "api": "Tc-99m Sestamibi",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TC99M-MIBI-2026-045",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalActivityMBq",
      "value": "925.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RadiochemicalPurityPercent",
      "value": "96.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "FreePertechnetatePercent",
      "value": "2.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ReducedHydrolyzedTcPercent",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH",
      "value": "5.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "EndotoxinsEU",
      "value": "12.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SterilityTest",
      "value": "0",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

OQ/PQ test scenarios

ID	Scenario	Expected result
OQ-001	Valid sample row	PASS or acceptable WARNING according to the rules.
OQ-002	Mandatory column missing	Schema error or FAIL.
OQ-003	Non-numeric value in numeric field	Type-conversion error.
OQ-004	Critical parameter outside limit	FAIL and critical finding.
PQ-001	User real batch/lot	Reviewed result with `input.csv` and `output.json` retained.

QA/QC and change control

Do not rename columns without updating the validator and test set.
Retain input.csv, output.json, executable version and checksum.
Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
Critical radiopharmaceutical limits must be verified against the approved specification and local SOPs.

Included in packages

Cardiology QC Suite

QC package for cardiology medicines: antihypertensives, anticoagulants, antiplatelets, lipid-lowering and antiarrhythmic medicines plus supporting QC checks.

Tc99mSestamibiQualityChecker

Utility description: Tc-99m Sestamibi

input.csv

URS & FS — User Requirements and Functional Specification

Domain limits and critical parameters

URS — User Requirements Specification

input.csv contract

FS — Functional Specification

Example output.json

OQ/PQ test scenarios

QA/QC and change control

Included in packages

Cardiology QC Suite

Endocrinology QC Suite

PetRad3: expanded PET/SPECT and radiopharmaceutical QC package

Radiology QC Suite

RPH isotope family: Tc-99m

RPH organ/system: cardiovascular

RPH organ/system: endocrine, thyroid and NET

RPH organ/system: hepatobiliary and GI

RPH use case: cardiac, bone and classic SPECT radiopharmaceuticals

RPH workflow: generators and isotope purity

RPH workflow: imaging QC and quantitative interpretation

RPH workflow: product release QC

RPH workflow: stability, storage, decay and waste

RPH workflow: synthesis, labelling and kit reconstitution

RPH: combined radiopharmaceutical QC package