Article: Urology QC Suite

QC package for urology: BPH, urolithiasis, overactive bladder, urinary-tract infection medicines and supporting antimicrobial QC checks.

Package purpose

QC package for urology: BPH, urolithiasis, overactive bladder, urinary-tract infection medicines and supporting antimicrobial QC checks.

Utility count: 57. 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…
2Alfuzosin Hydrochloridealfuzosin hydrochlorideAlfuzosin Hydrochloride Quality Checker — Alfuzosin hydrochloride quality assessment (BP/Ph.
3AtezolizumabatezolizumabAtezolizumab Quality Checker — Biologic Drug (Anti-PD-L1 mAb) (Ph.
4Cefadroxil Monohydratecefadroxil monohydrateCefadroxil Monohydrate Quality Checker — Cefadroxil monohydrate quality assessment (BP/Ph.
5Cefalexin Monohydratecefalexin monohydrateCefalexin Monohydrate Quality Checker — Cefalexin monohydrate quality assessment (BP/Ph.
6CefiximecefiximeCefixime Quality Checker — Cefixime quality assessment (BP/Ph.
7Cefoperazone Sodiumcefoperazone sodiumCefoperazone Sodium Quality Checker — Cefoperazone sodium quality assessment (BP/Ph.
8CeftriaxoneceftriaxoneCeftriaxone Quality Checker — 3rd Generation Cephalosporin (Ph.
9Cefuroxime Axetilcefuroxime axetilCefuroxime Axetil Quality Checker — Cefuroxime axetil quality assessment (BP/Ph.
10CiprofloxacinciprofloxacinCiprofloxacin Quality Checker — Ciprofloxacin quality assessment (BP/Ph.
11Copper67copper67Copper-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.
12Doxazosin Mesilatedoxazosin mesilateDoxazosin Mesilate Quality Checker — Doxazosin mesilate quality assessment (Ph.
13DutasteridedutasterideDutasteride Quality Checker — Dutasteride quality assessment (BP/Ph.
14FinasteridefinasterideFinasteride Quality Checker — Finasteride quality assessment (Ph.
15Fluorine18 FDGfluorine18 fdgquality checkerFluorine-18 FDG Quality Checker — ¹⁸F-FDG (fluorodeoxyglucose) for PET diagnostics (Ph.
16Fluorine18 Na Ffluorine18 na fquality checkerFluorine-18 NaF Quality Checker — Sodium [18F]fluoride for bone PET imaging (Ph.
17Fluorine18 PSMAfluorine18 psmaquality checkerFluorine-18 PSMA Quality Checker — ¹⁸F-PSMA-1007 for prostate cancer PET imaging (Ph.
18Gallium68 Generatorgallium68 generatorGallium-68 Generator Quality Checker — ⁶⁸Ge/⁶⁸Ga generator for PET diagnostics (Ph.
19Gallium68 PSMAgallium68 psmaquality checkerGallium-68 PSMA Quality Checker — ⁶⁸Ga-PSMA-11 for prostate cancer PET imaging (Ph.
20Gamma 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).
21Gemcitabine Hydrochloridegemcitabine hydrochlorideGemcitabine Hydrochloride Quality Checker — Gemcitabine hydrochloride quality assessment (BP/Ph.
22Generator 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…
23Lead212lead212Lead-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%),…
24LevofloxacinlevofloxacinLevofloxacin Quality Checker — Levofloxacin quality assessment (Ph.
25Lutetium177 PSMAlutetium177 psmaquality checkerLutetium-177 PSMA Quality Checker — Lutetium-177 PSMA-617 solution (targeted therapy for prostate cancer) (Ph.
26MirabegronmirabegronMirabegron Quality Checker — Beta-3 Agonist (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized/hydrolysis impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL…
27NitrofurantoinnitrofurantoinNitrofurantoin Quality Checker — Antibacterial Agent (Ph.
28OfloxacinofloxacinOfloxacin Quality Checker — Ofloxacin quality assessment (Ph.
29Ofloxacin Ornidazoleofloxacin ornidazoleOfloxacin Ornidazole Quality Checker — Combo Antibiotic/Antiprotozoal ℹ️ The utility checks content of both APIs, nitro-impurities, synchronous dissolution.
30OlaparibolaparibOlaparib 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…
31OxybutyninoxybutyninOxybutynin Quality Checker — Antispasmodic (Ph. Eur., USP) ️ The utility checks assay, isomer/hydrolysis/oxidized impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ️ CRITICAL!
32Radiation 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…
33Radium223 Dichlorideradium223 dichlorideRadium-223 Dichloride Quality Checker — Radium-223 dichloride solution (Xofigo®) (Ph.
34Sildenafil Citratesildenafil citrateSildenafil Citrate Quality Checker — Sildenafil citrate quality assessment (Ph.
35SolifenacinsolifenacinSolifenacin Quality Checker — Antimuscarinic Agent (Ph.
36Strontium89 Chloridestrontium89 chlorideStrontium-89 Chloride Quality Checker — Strontium-89 chloride solution (Metastron®) (Ph.
37TadalafiltadalafilTadalafil Quality Checker — Tadalafil quality assessment (Ph.
38Tamsulosin Hydrochloridetamsulosin hydrochlorideTamsulosin Hydrochloride Quality Checker — Tamsulosin hydrochloride quality assessment (Ph.
39TolterodinetolterodineTolterodine Quality Checker — Antimuscarinic Agent (Ph.
40Astatine-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.
41Bismuth-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.
42Terbium-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.
43Copper-64 ATSMcopper64 atsmCopper-64 ATSM Quality Checker — Copper-64 ATSM for PET Hypoxia Imaging ℹ️ Utility checks critical parameters of [64Cu]Cu-ATSM: • Radionuclidic purity (≥99.
44Fluorine-18 Cholinefluorine18 cholineFluorine-18 Choline Quality Checker — Fluorine-18 Choline for PET Oncology ℹ️ Utility checks critical parameters of [18F]Fluorocholine: • Radionuclidic purity (≥99.
45Fluorine-18 FMISOfluorine18 fmisoFluorine-18 FMISO Quality Checker — Fluorine-18 FMISO for PET Hypoxia Imaging ℹ️ Utility checks critical parameters of [18F]FMISO (Fluoromisonidazole): • Radionuclidic purity (≥99.
46Gallium-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.
47Indium-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…
48Lutetium-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.
49Palladium-103palladium103Palladium-103 Quality Checker — Palladium-103 for Brachytherapy ℹ️ Utility checks critical parameters of Palladium-103: • Radionuclidic purity (≥99.
50Tc-99m MAG3tc99m mag3Tc-99m MAG3 Quality Checker — Technetium-99m Mercaptide (MAG3) for Dynamic Renal Scintigraphy ℹ️ Utility checks critical parameters of Tc-99m MAG3: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5%) • Boil…
51Ceftriaxone Sodium Purity Checkerceftriaxone sodium purity checkerUtility description: Ceftriaxone Sodium Purity Checker Ceftriaxone Sodium Purity Checker — Ceftriaxone Sodium Purity Control ℹ️ Utility checks critical quality parameters of ceftriaxone sodium: • Assay (96.
52Ciprofloxacin Impurity Checkerciprofloxacin impurity checkerUtility description: Ciprofloxacin Impurity Checker Ciprofloxacin Impurity Checker — Ciprofloxacin Impurity Control ℹ️ Utility checks critical quality parameters of ciprofloxacin: • Assay (98.
53Drotaverine Hydrochloride Quality Checkerdrotaverine hydrochloride checkerUtility description: Drotaverine Hydrochloride Quality Checker Drotaverine Hydrochloride Quality Checker — Drotaverine Hydrochloride (No-Spa) ℹ️ Utility checks critical parameters of Drotaverine Hydrochloride API: • Assay (99.
54InfraLUM ID Ceftriaxoneinfra lum id ceftriaxoneUtility description: InfraLUM ID Ceftriaxone InfraLUM ID Ceftriaxone — Ceftriaxone Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
55InfraLUM ID Ciprofloxacininfra lum id ciprofloxacinUtility description: InfraLUM ID Ciprofloxacin InfraLUM ID Ciprofloxacin — Ciprofloxacin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
56InfraLUM ID Levofloxacininfra lum id levofloxacinUtility description: InfraLUM ID Levofloxacin InfraLUM ID Levofloxacin — Levofloxacin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
57Levofloxacin Optical Isomer Checkerlevofloxacin optical isomer checkerUtility description: Levofloxacin Optical Isomer Checker Levofloxacin Optical Isomer Checker — Control of Levofloxacin Optical Isomerism ℹ️ Utility checks critical chiral purity parameters of levofloxacin: • Content of active S-(-)-isomer (…