Tc99mMDPBoneScanQualityChecker

Tc-99m MDP Bone Scan Quality Checker

api radiopharmaceuticals nuclear-medicine tc-99m spect bone-imaging
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Tc-99m MDP Bone Scan Quality Checker — Quality control of Tc-99m MDP for bone scintigraphy

ℹ️ Utility checks critical parameters of Tc-99m MDP:

  • Radiochemical purity (≥90%)
  • Free technetium (<5%)
  • Colloidal technetium (<5%)
  • pH, shelf-life, endotoxins, sterility

⚠️ CRITICAL: Colloidal technetium accumulates in liver, masking metastases!

Tc-99m MDP is most common drug for skeletal scintigraphy.

Complex stability is limited to 6 hours.

Usage

Tc99mMDPBoneScanQualityChecker.exe → demo mode (console output)

Tc99mMDPBoneScanQualityChecker.exe input.csv output.json → evaluate your data

Input format

BatchNumber,RadiochemicalPurityPercent,FreeTechnetiumPercent,HydrolyzedReducedTcPercent,pH,TimeSincePreparationMin,ActivityMBq,SterilityTest,EndotoxinsEU_per_mL

Example

MDP-2026-001,96.0,2.0,2.0,7.0,30.0,1000.0,0,10.0

— WHY IS THIS NEEDED?

Tc-99m MDP (Methylenediphosphonate) is gold standard for skeleton imaging.

  • Mechanism: chemosorption on bone hydroxyapatite surface.
  • Requires high radiochemical purity to avoid accumulation in soft tissues.
  • Free technetium gives background in thyroid and stomach.
  • Colloidal technetium (hydrolyzed) gives background in liver and spleen.

⚠️ CRITICAL:

  • Radiochemical purity ≥90% (recommended >95%) — guarantee of high bone/soft tissue contrast.
  • Free technetium <5% — minimization of artifacts.
  • Colloidal technetium <5% — critical for excluding false positives in abdominal cavity.
  • pH 6.0-8.0 — complex stability.
  • Time since preparation ≤6 hours — in vitro stability limit.
  • Endotoxins <175 EU/mL — standard for parenteral drugs.
  • Sterility — MANDATORY.

Key features

  • Separate control of free and colloidal technetium.
  • Drug shelf-life monitoring.
  • Suitability assessment for mass diagnostics.
  • Compliance with Pharmacopoeia requirements for Tc-99m radiopharmaceuticals.

Critical parameters

  • Radiochemical purity: ≥90.0%
  • Free technetium: <5.0%
  • Colloidal technetium: <5.0%
  • pH: 6.0–8.0
  • Time since preparation: ≤360 min (6 h)
  • Endotoxins: <175 EU/mL
  • Sterility: no growth

💡 Usage tips:

1. Radiochemical purity determined by TLC (two solvents: acetone and saline).

2. Protect drug from light.

3. Use drug within 4-6 hours after preparation for maximum efficacy.

4. If high colloid levels, check generator eluate quality (aluminum presence).

5. MDP is stable at room temperature.

⚠️ Note: Tc-99m MDP is most frequently used radiopharmaceutical in world. Quality of this drug directly affects diagnostic ability to detect small metastases and stress fractures. Even small amount of colloids can create serious diagnostic confusion.

input.csv

BatchNumber,RadiochemicalPurityPercent,FreeTechnetiumPercent,HydrolyzedReducedTcPercent,pH,TimeSincePreparationMin,ActivityMBq,SterilityTest,EndotoxinsEU_per_mL
MDP-2026-001,96.0,2.0,2.0,7.0,30.0,1000.0,0,10.0
MDP-2026-002,92.0,4.0,4.0,6.8,120.0,900.0,0,15.0
MDP-2026-003,85.0,8.0,7.0,7.5,400.0,800.0,1,20.0

URS & FS — user requirements and functional specification

URS — User Requirements Specification

  • The utility shall accept input.csv with these mandatory columns: BatchNumber, RadiochemicalPurityPercent, FreeTechnetiumPercent, HydrolyzedReducedTcPercent, pH, TimeSincePreparationMin, ActivityMBq, SterilityTest, EndotoxinsEU_per_mL.
  • 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

  1. Run Tc99mMDPBoneScanQualityChecker.exe in demonstration mode or with input.csv output.json arguments.
  2. Read UTF-8 CSV and verify the exact set of mandatory columns.
  3. Convert row values to numeric and text types.
  4. Apply the rules defined in the approved version or configuration profile.
  5. Generate individual check results and derive the overall status from the most severe violation.
  6. Write machine-readable output.json.
  7. Structural and type errors shall be reported explicitly and shall not be masked by a successful status.

Complete input.csv example

BatchNumber,RadiochemicalPurityPercent,FreeTechnetiumPercent,HydrolyzedReducedTcPercent,pH,TimeSincePreparationMin,ActivityMBq,SterilityTest,EndotoxinsEU_per_mL
MDP-2026-001,96.0,2.0,2.0,7.0,30.0,1000.0,0,10.0
MDP-2026-002,92.0,4.0,4.0,6.8,120.0,900.0,0,15.0
MDP-2026-003,85.0,8.0,7.0,7.5,400.0,800.0,1,20.0

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": "Tc99mMDPBoneScanQualityChecker",
  "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

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A curated suite for PET/SPECT radiopharmaceuticals, generator and cyclotron radionuclides, labelled compounds, radiochemical purity, breakthrough, sterility and endotoxin control.

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

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Radiopharmaceutical Diagnostics and Therapy QC Suite

36 utilities for clinically oriented radiopharmaceutical and workflow quality control: PET/SPECT tracers, the Tc-99m renal workflow, PRRT, PSMA therapy, targeted alpha therapy, radioembolization, bone-pain palliation, immuno-PET and generator-based radionuclide control.

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RPH isotope family: Tc-99m

Tc-99m radiopharmaceuticals, kit preparation, generator control, SPECT workflows and calculation utilities.

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Bone scintigraphy, MDP/PYP, marrow, bone-pain palliation, skeletal metastases and radiosynovectomy.

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RPH organ/system: endocrine, thyroid and NET

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RPH organ/system: hepatobiliary and GI

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RPH use case: cardiac, bone and classic SPECT radiopharmaceuticals

Sestamibi, tetrofosmin, MDP, pyrophosphate, thallium and related quality checks for cardiology, bone imaging and classic SPECT protocols.

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RPH workflow: generators and isotope purity

Generator eluate, breakthrough, radionuclidic purity, isotope mix and starting radionuclides.

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RPH workflow: imaging QC and quantitative interpretation

Acquisition, uptake, clearance, perfusion, transit, ejection fraction, segmentation and quantitative imaging.

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RPH workflow: product release QC

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

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RPH workflow: stability, storage, decay and waste

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

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RPH: combined radiopharmaceutical QC package

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