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Article: Andrology QC Suite

QC package for andrology: androgens, erectile-dysfunction medicines, BPH/prostate products, fertility and related hormonal checks.

Package purpose

QC package for andrology: androgens, erectile-dysfunction medicines, BPH/prostate products, fertility and related hormonal checks.

Utility count: 33. The package is intended for QC laboratories, QA, CSV and LIMS/ELN/MES integration.

Data

Typical flow: instrument or LIMS creates input.csv, the utility performs rule-based checks and returns output.json.

Validation

Each utility is supported by URS/FS and scenarios that can be used for IQ/OQ/PQ preparation.

Licensing

Licensing can be discussed as an as-is legal-entity licence without resale rights, a LIMS/ELN/MES integration module, or a pilot package for a production site/laboratory. Representative contacts are rendered from the portal configuration.

Utilities and checked parameters

#API / productUtilityKey checks
1Actinium225actinium225Actinium-225 Quality Checker — Actinium-225 for targeted alpha therapy (TAT) ℹ️ Utility checks critical parameters of actinium-225: • Specific activity (≥500 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Free actinium (≤5% for co…
2Clomifene Citrateclomifene citrateClomifene Citrate Quality Checker — Clomifene citrate quality assessment (Ph.
3Copper67copper67Copper-67 Quality Checker — Copper-67 for targeted radionuclide therapy ℹ️ Utility checks critical parameters of copper-67: • Specific activity (≥100 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Copper-64 impurity (≤0.
4Doxazosin Mesilatedoxazosin mesilateDoxazosin Mesilate Quality Checker — Doxazosin mesilate quality assessment (Ph.
5DutasteridedutasterideDutasteride Quality Checker — Dutasteride quality assessment (BP/Ph.
6Enalapril Maleateenalapril maleateEnalapril Maleate Quality Checker — Enalapril maleate quality assessment (BP/Ph.
7FinasteridefinasterideFinasteride Quality Checker — Finasteride quality assessment (Ph.
8Fluorine18 Na Ffluorine18 na fquality checkerFluorine-18 NaF Quality Checker — Sodium [18F]fluoride for bone PET imaging (Ph.
9Fluorine18 PSMAfluorine18 psmaquality checkerFluorine-18 PSMA Quality Checker — ¹⁸F-PSMA-1007 for prostate cancer PET imaging (Ph.
10Gallium68 Generatorgallium68 generatorGallium-68 Generator Quality Checker — ⁶⁸Ge/⁶⁸Ga generator for PET diagnostics (Ph.
11Gallium68 PSMAgallium68 psmaquality checkerGallium-68 PSMA Quality Checker — ⁶⁸Ga-PSMA-11 for prostate cancer PET imaging (Ph.
12Gamma Index Analyzergamma index analyzerGamma Index Analyzer — Dose Agreement Analysis (AAPM TG-218) ℹ️ The utility calculates Gamma Analysis Pass Rate for RT plan verification (VMAT, IMRT, SRS).
13Generator Elution Predictorgenerator elution predictorGenerator Elution Predictor — Generator elution activity predictor ℹ️ Utility calculates PREDICTED daughter nuclide activity in generator eluate: • Accounts for parent nuclide decay since calibration • Accounts for daughter nuclide ingrowth…
14Lead212lead212Lead-212 Quality Checker — Lead-212 for targeted alpha therapy (TAT) ℹ️ Utility checks critical parameters of lead-212: • Specific activity (≥100 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Daughter nuclides: bismuth-212 (≤5%),…
15Lutetium177 PSMAlutetium177 psmaquality checkerLutetium-177 PSMA Quality Checker — Lutetium-177 PSMA-617 solution (targeted therapy for prostate cancer) (Ph.
16OlaparibolaparibOlaparib Quality Checker — PARP Inhibitor (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized/hydrolysis impurities, toluene/acetonitrile/dichloromethane, dissolution profile. ℹ️ Does not use machine learning — rule-based logic onl…
17Radiation Dose Calculatorradiation dose calculatorRadiation Dose Calculator — Patient absorbed dose calculator ℹ️ Utility calculates ESTIMATED absorbed dose based on ICRP data (ICRP 106, 128): • Effective dose (mSv) for overall radiation burden assessment • Target organ and critical organ…
18Radium223 Dichlorideradium223 dichlorideRadium-223 Dichloride Quality Checker — Radium-223 dichloride solution (Xofigo®) (Ph.
19Sildenafil Citratesildenafil citrateSildenafil Citrate Quality Checker — Sildenafil citrate quality assessment (Ph.
20Strontium89 Chloridestrontium89 chlorideStrontium-89 Chloride Quality Checker — Strontium-89 chloride solution (Metastron®) (Ph.
21TadalafiltadalafilTadalafil Quality Checker — Tadalafil quality assessment (Ph.
22Tamsulosin Hydrochloridetamsulosin hydrochlorideTamsulosin Hydrochloride Quality Checker — Tamsulosin hydrochloride quality assessment (Ph.
23TestosteronetestosteroneTestosterone Quality Checker — Testosterone quality assessment (BP/Ph.
24Testosterone Undecanoatetestosterone undecanoateTestosterone Undecanoate Quality Checker — Testosterone Undecanoate (Testosterone Ester for Replacement Therapy) (Ph.
25Astatine-211astatine211Utility description: Astatine-211 Astatine-211 Quality Checker — Astatine-211 for targeted alpha therapy ℹ️ Utility checks critical parameters of astatine-211: • Radionuclidic purity (≥99.
26Bismuth-213bismuth213Utility description: Bismuth-213 Bismuth-213 Quality Checker — Bismuth-213 for targeted alpha therapy ℹ️ Utility checks critical parameters of bismuth-213: • Radionuclidic purity (≥99.
27Terbium-161terbium161Utility description: Terbium-161 Terbium-161 Quality Checker — Terbium-161 for targeted radionuclide therapy ℹ️ Utility checks critical parameters of terbium-161: • Radionuclidic purity (≥99.
28Fluorine-18 Cholinefluorine18 cholineFluorine-18 Choline Quality Checker — Fluorine-18 Choline for PET Oncology ℹ️ Utility checks critical parameters of [18F]Fluorocholine: • Radionuclidic purity (≥99.
29Gallium-68 HBED-CCgallium68 hbedccGallium-68 HBED-CC Quality Checker — Gallium-68 PSMA (HBED-CC) for PET Prostate Cancer Imaging ℹ️ Utility checks critical parameters of [68Ga]Ga-PSMA-11 (HBED-CC): • Radionuclidic purity (≥99.
30Indium-111 Capromab Pendetideindium111 capromab pendetide checkerIndium-111 Capromab Pendetide Quality Checker — Indium-111 Capromab Pendetide (ProstaScint®) ℹ️ Utility checks critical parameters of the monoclonal antibody-based radiopharmaceutical: • Radiochemical purity (≥90%) • Free Indium-111 impurit…
31Lutetium-177 J591lutetium177 j591Lutetium-177 J591 Quality Checker — Lutetium-177 J591 (Anti-PSMA mAb) for prostate cancer therapy ℹ️ Utility checks critical parameters of Lutetium-177 J591: • Radionuclidic purity (≥99.
32Palladium-103palladium103Palladium-103 Quality Checker — Palladium-103 for Brachytherapy ℹ️ Utility checks critical parameters of Palladium-103: • Radionuclidic purity (≥99.
33InfraLUM ID Amlodipineinfra lum id amlodipineUtility description: InfraLUM ID Amlodipine InfraLUM ID Amlodipine — Amlodipine Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.