Article: Neurology QC Suite

QC package for neurology and neuropsychiatry: antiepileptics, antiparkinsonian medicines, antidepressants, antipsychotics, analgesics and neurological diagnostic radiopharmaceuticals.

Package purpose

QC package for neurology and neuropsychiatry: antiepileptics, antiparkinsonian medicines, antidepressants, antipsychotics, analgesics and neurological diagnostic radiopharmaceuticals.

Utility count: 121. 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…
2Almotriptan Malatealmotriptan malateAlmotriptan Malate Quality Checker — Almotriptan malate quality assessment (BP/Ph.
3Amantadine Hydrochlorideamantadine hydrochlorideAmantadine Hydrochloride Quality Checker — Amantadine hydrochloride quality assessment (BP/Ph.
4AmisulprideamisulprideAmisulpride Quality Checker — Amisulpride quality assessment (BP/Ph.
5Amitriptyline Hydrochlorideamitriptyline hydrochlorideAmitriptyline Hydrochloride Quality Checker — Amitriptyline hydrochloride quality assessment (BP/Ph.
6Apomorphine Hydrochlorideapomorphine hydrochlorideApomorphine Hydrochloride Quality Checker — Apomorphine hydrochloride quality assessment (BP/Ph.
7AprepitantaprepitantAprepitant Quality Checker — Aprepitant quality assessment (BP/Ph.
8AripiprazolearipiprazoleAripiprazole Quality Checker — Aripiprazole quality assessment (BP/Ph.
9BaclofenbaclofenBaclofen Quality Checker — Baclofen quality assessment (BP/Ph.
10BenperidolbenperidolBenperidol Quality Checker — Benperidol quality assessment (BP/Ph.
11Bromocriptine Mesilatebromocriptine mesilateBromocriptine Mesilate Quality Checker — Bromocriptine mesilate quality assessment (BP/Ph.
12BupropionbupropionBupropion Quality Checker — Antidepressant (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, impurities, dissolution profile (for SR/XL), residual solvents. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL…
13CabergolinecabergolineCabergoline Quality Checker — Cabergoline quality assessment (BP/Ph.
14CarbamazepinecarbamazepineCarbamazepine Quality Checker — Carbamazepine quality assessment (BP/Ph.
15CarbidopacarbidopaCarbidopa Quality Checker — Carbidopa quality assessment (BP/Ph.
16ChlorpromazinechlorpromazineChlorpromazine Quality Checker — Chlorpromazine quality assessment (Ph.
17CinnarizinecinnarizineCinnarizine Quality Checker — Cinnarizine quality assessment (BP/Ph.
18CisplatincisplatinCisplatin Quality Checker — Platinum Cytostatic (Ph.
19Citalopram Hydrobromidecitalopram hydrobromideCitalopram Hydrobromide Quality Checker — Citalopram hydrobromide quality assessment (BP/Ph.
20Clarity And Opalescenceclarity and opalescence checkerClarity and Opalescence Checker — Проверка прозрачности и опалесценции (Ph.
21Clomipramine Hydrochlorideclomipramine hydrochlorideClomipramine Hydrochloride Quality Checker — Clomipramine hydrochloride quality assessment (BP/Ph.
22ClonazepamclonazepamClonazepam Quality Checker — Clonazepam quality assessment (BP/Ph.
23ClozapineclozapineClozapine Quality Checker — Clozapine quality assessment (BP/Ph.
24Codeine Phosphatecodeine phosphateCodeine Phosphate Quality Checker — Codeine phosphate quality assessment (Ph.
25Copper67copper67Copper-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.
26CyclobenzaprinecyclobenzaprineCyclobenzaprine Quality Checker — Muscle Relaxant (Ph.
27Cyproheptadine Hydrochloridecyproheptadine hydrochlorideCyproheptadine Hydrochloride Quality Checker — Cyproheptadine hydrochloride quality assessment (BP/Ph.
28DomperidonedomperidoneDomperidone Quality Checker — Domperidone quality assessment (BP/Ph.
29DonepezildonepezilDonepezil Quality Checker — AChE Inhibitor (Ph. Eur., USP) ℹ️ The utility checks assay, chloride/oxidized impurities, toluene, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
30Dopamine Hydrochloridedopamine hydrochlorideDopamine Hydrochloride Quality Checker — Dopamine hydrochloride quality assessment (BP/Ph.
31Doxepin Hydrochloridedoxepin hydrochlorideDoxepin Hydrochloride Quality Checker — Doxepin hydrochloride quality assessment (Ph.
32Duloxetine Hydrochlorideduloxetine hydrochlorideDuloxetine Hydrochloride Quality Checker — Duloxetine hydrochloride quality assessment (BP/Ph.
33EntacaponeentacaponeEntacapone Quality Checker — Entacapone quality assessment (BP/Ph.
34Ethambutol Hydrochlorideethambutol hydrochlorideEthambutol Hydrochloride Quality Checker — Ethambutol hydrochloride quality assessment (Ph.
35FentanylfentanylFentanyl Quality Checker — Fentanyl quality assessment (BP/Ph.
36Fluorine18 FDGfluorine18 fdgquality checkerFluorine-18 FDG Quality Checker — ¹⁸F-FDG (fluorodeoxyglucose) for PET diagnostics (Ph.
37Fluoxetine Hydrochloridefluoxetine hydrochlorideFluoxetine Hydrochloride Quality Checker — Fluoxetine hydrochloride quality assessment (BP/Ph.
38FluphenazinefluphenazineFluphenazine Quality Checker � Fluphenazine quality assessment (BP/Ph.
39GabapentingabapentinGabapentin Quality Checker — Gabapentin quality assessment (BP/Ph.
40Gabapentin Methylcobalamingabapentin methylcobalaminGabapentin Methylcobalamin Quality Checker — Combo Product (Neurotropic) ℹ️ The utility checks content of both APIs, B12 degradation, content uniformity, dissolution.
41Galantamine Hydrobromidegalantamine hydrobromideGalantamine Hydrobromide Quality Checker — Galantamine hydrobromide quality assessment (BP/Ph.
42Gallium68 DOTATATEgallium68 dotatatequality checkerGallium-68 DOTATATE Quality Checker — ⁶⁸Ga-DOTATATE (NETSPOT®) for neuroendocrine tumor PET imaging (Ph.
43Gallium68 Generatorgallium68 generatorGallium-68 Generator Quality Checker — ⁶⁸Ge/⁶⁸Ga generator for PET diagnostics (Ph.
44Gallium68 PSMAgallium68 psmaquality checkerGallium-68 PSMA Quality Checker — ⁶⁸Ga-PSMA-11 for prostate cancer PET imaging (Ph.
45HaloperidolhaloperidolHaloperidol Quality Checker — Haloperidol quality assessment (BP/Ph.
46Imipramine Hydrochlorideimipramine hydrochlorideImipramine Hydrochloride Quality Checker — Imipramine hydrochloride quality assessment (BP/Ph.
47IodixanoliodixanolIodixanol Quality Checker — Radiographic Contrast Agent (Ph.
48IopamidoliopamidolIopamidol Quality Checker — Radiographic Contrast Agent (Ph.
49LacosamidelacosamideLacosamide Quality Checker — Lacosamide quality assessment (BP/Ph.
50LamotriginelamotrigineLamotrigine Quality Checker — Lamotrigine quality assessment (BP/Ph.
51Lead212lead212Lead-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%),…
52LevetiracetamlevetiracetamLevetiracetam Quality Checker — Levetiracetam quality assessment (BP/Ph.
53Lithium Carbonatelithium carbonateLithium Carbonate Quality Checker — Lithium carbonate quality assessment (BP/Ph.
54Lutetium177 DOTATATElutetium177 dotatatequality checkerLutetium-177 DOTATATE Quality Checker — Lutetium-177 DOTATATE solution (Lutathera®) (Ph.
55MemantinememantineMemantine Quality Checker — Neuroprotector (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized/dealkylated impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL…
56MethylphenidatemethylphenidateMethylphenidate Quality Checker — Psychostimulant (Ph.
57Mianserin Hydrochloridemianserin hydrochlorideMianserin Hydrochloride Quality Checker — Mianserin hydrochloride quality assessment (BP/Ph.
58MirtazapinemirtazapineMirtazapine Quality Checker — Mirtazapine quality assessment (BP/Ph.
59Morphine Hydrochloridemorphine hydrochlorideMorphine Hydrochloride Quality Checker — Morphine hydrochloride quality assessment (BP/Ph.
60NimodipinenimodipineNimodipine Quality Checker — Nimodipine quality assessment (Ph.
61NitrazepamnitrazepamNitrazepam Quality Checker — Nitrazepam quality assessment (BP/Ph.
62NortriptylinenortriptylineNortriptyline Quality Checker — Tricyclic Antidepressant (Ph.
63OlanzapineolanzapineOlanzapine Quality Checker — Olanzapine quality assessment (Ph.
64OpiumopiumOpium Quality Checker — Quality control of Opium (poppy latex) ⚠️ FOR LICENSED PHARMACEUTICAL USE ONLY ℹ️ The utility checks morphine, codeine, thebaine content, loss on drying, and total ash.
65Osmolality Validatorosmolality validatorOsmolality Validator — Osmolality assessment (Ph. Eur. 2.2.35) ℹ️ The utility verifies that solution osmolality complies with European Pharmacopoeia requirements. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ For eye drops: 2…
66OxcarbazepineoxcarbazepineOxcarbazepine Quality Checker — Oxcarbazepine quality assessment (Ph.
67Pantothenic Acidpantothenic acidPantothenic Acid Quality Checker — Vitamin B5, Calcium Pantothenate (Ph.
68ParoxetineparoxetineParoxetine Quality Checker — Antidepressant (SSRI) (Ph.
69PhenobarbitalphenobarbitalPhenobarbital Quality Checker — Phenobarbital quality assessment (BP/Ph.
70PhenytoinphenytoinPhenytoin Quality Checker — Phenytoin quality assessment (Ph.
71PregabalinpregabalinPregabalin Quality Checker — Pregabalin quality assessment (BP/Ph.
72Pregabalin Methylcobalaminpregabalin methylcobalaminPregabalin Methylcobalamin Quality Checker — Combo Product (Neurotropic) ℹ️ The utility checks content of both APIs, Pregabalin R-enantiomer, B12 degradation, content uniformity.
73Propranolol Hydrochloridepropranolol hydrochloridePropranolol Hydrochloride Quality Checker — Propranolol hydrochloride quality assessment (Ph.
74Pyridoxine Hydrochloridepyridoxine hydrochloridePyridoxine Hydrochloride Quality Checker — Vitamin B6 (Ph.
75Quetiapine Fumaratequetiapine fumarateQuetiapine Fumarate Quality Checker — Quetiapine fumarate quality assessment (BP/Ph.
76RisperidonerisperidoneRisperidone Quality Checker — Risperidone quality assessment (BP/Ph.
77RivastigminerivastigmineRivastigmine Quality Checker — Rivastigmine quality assessment (BP/Ph.
78RufinamiderufinamideRufinamide Quality Checker — Rufinamide quality assessment (Ph.
79Sertraline Hydrochloridesertraline hydrochlorideSertraline Hydrochloride Quality Checker — Sertraline hydrochloride quality assessment (BP/Ph.
80SirolimussirolimusSirolimus Quality Checker — Immunosuppressant (Ph. Eur., USP) ️ The utility checks assay, isomers, macrolide oxidation, hexane/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ️ CRITICAL!
81St John S Wort Herbst john swort herbSt. John's Wort Herb Quality Checker — Quality control of St. John's wort herb ℹ️ The utility checks hypericin and hyperforin content, loss on drying, total ash, and ash insoluble in HCl. ℹ️ Related to universal utilities: HerbalDrugQuality…
82SumatriptansumatriptanSumatriptan Quality Checker — Sumatriptan quality assessment (Ph.
83Thiamine Hydrochloridethiamine hydrochlorideThiamine Hydrochloride Quality Checker — Vitamin B1 (Ph.
84Tiagabine Hydrochloridetiagabine hydrochlorideTiagabine Hydrochloride Quality Checker — Tiagabine hydrochloride quality assessment (BP/Ph.
85Tianeptine Sodiumtianeptine sodiumTianeptine Sodium Quality Checker — Tianeptine sodium quality assessment (BP/Ph.
86TopiramatetopiramateTopiramate Quality Checker — Topiramate quality assessment (Ph.
87Tramadol Hydrochloridetramadol hydrochlorideTramadol Hydrochloride Quality Checker — Tramadol hydrochloride quality assessment (Ph.
88Tranylcypromine Sulfatetranylcypromine sulfateTranylcypromine Sulfate Quality Checker — Tranylcypromine sulfate quality assessment (BP/Ph.
89Trazodone Hydrochloridetrazodone hydrochlorideTrazodone Hydrochloride Quality Checker — Trazodone hydrochloride quality assessment (Ph.
90Valproic Acidvalproic acidValproic Acid Quality Checker — Anticonvulsant (Ph.
91Venlafaxine Hydrochloridevenlafaxine hydrochlorideVenlafaxine Hydrochloride Quality Checker — Venlafaxine hydrochloride quality assessment (BP/Ph.
92Yttrium90yttrium90Yttrium-90 Quality Checker — Yttrium-90 for radionuclide therapy ℹ️ Utility checks critical parameters of yttrium-90: • Specific activity (≥1000 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Yttrium-88 impurity (≤0.
93Astatine-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.
94Bismuth-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.
95Terbium-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.
96Copper-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.
97Copper-64 DOTATATEcopper64 dotatateCopper-64 DOTATATE Quality Checker — Copper-64 DOTATATE for PET Imaging of Neuroendocrine Tumors ℹ️ Utility checks critical parameters of [64Cu]Cu-DOTATATE: • Radionuclidic purity (≥99.
98Fluorine-18 Amyloidfluorine18 amyloidFluorine-18 Amyloid Quality Checker — Fluorine-18 Amyloid Tracers for Alzheimer's Disease PET Imaging ℹ️ Utility checks critical parameters of F-18 amyloid imaging agents (Florbetapir, Flutemetamol, Florbetaben): • Radionuclidic purity (≥99…
99Fluorine-18 DOPAfluorine18 dopaFluorine-18 DOPA Quality Checker — Fluorine-18 DOPA for PET Diagnostics ℹ️ Utility checks critical parameters of [18F]FDOPA: • Radionuclidic purity (≥99.
100Fluorine-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.
101Indium-111 Pentetreotideindium111 pentetreotideIndium-111 Pentetreotide Quality Checker — Indium-111 Pentetreotide (OctreoScan®) ℹ️ Utility checks critical parameters of the somatostatin analog radiopharmaceutical: • Radiochemical purity (≥90%) • Free Indium-111 impurity (≤5%) • Colloid…
102Iodine-123 FP-CITiodine123 fpctIodine-123 FP-CIT Quality Checker — Ioflupane I-123 (DaTscan®) ℹ️ Utility checks critical parameters of the radiopharmaceutical for dopamine transporter imaging: • Radiochemical purity (≥95%) • Free Iodine-123 impurity (≤5%) • Radionuclidic…
103Iodine-123 Ioflupaneiodine123 ioflupaneIodine-123 Ioflupane Quality Checker — Ioflupane I-123 (DaTscan®) ℹ️ Utility checks critical parameters of the radiopharmaceutical for dopamine transporter imaging: • Radiochemical purity (≥95%) • Free Iodine-123 impurity (≤5%) • Radionucli…
104Iodine-123 MIBGiodine123 mibgIodine-123 MIBG Quality Checker — Iodine-123 Metaiodobenzylguanidine ℹ️ Utility checks critical parameters of Iodine-123 MIBG radiopharmaceutical: • Radiochemical purity (≥95%) • Free Iodine-123 impurity (≤5%) • Radionuclidic impurity Iodin…
105Iodine-131 MIBGiodine131 mibgIodine-131 MIBG Quality Checker — Iodine-131 MIBG for neuroendocrine tumor therapy ℹ️ Utility checks critical parameters of Iodine-131 MIBG: • Radionuclidic purity (≥99.
106Lutetium-177 DOTATOClutetium177 dotatocLutetium-177 DOTATOC Quality Checker — Lutetium-177 DOTATOC for Peptide Receptor Radionuclide Therapy (PRRT) ℹ️ Utility checks critical parameters of Lutetium-177 DOTATOC: • Radionuclidic purity (≥99.
107Scandium-43scandium43Scandium-43 Quality Checker — Scandium-43 for PET Imaging (Theranostics) ℹ️ Utility checks critical parameters of Scandium-43: • Radionuclidic purity (≥99.
108Tc-99m HMPAOtc99m hmpaoTc-99m HMPAO Quality Checker — Technetium-99m HMPAO for Brain SPECT Perfusion ℹ️ Utility checks critical parameters of Tc-99m HMPAO: • Radiochemical purity of lipophilic complex (≥80%) • Secondary complex (≤15%) • Free pertechnetate (≤5%) •…
109Tc-99m ECDtechnetium99m ecdTc-99m ECD Quality Checker — Technetium-99m Bicisate (ECD) for Brain SPECT Perfusion ℹ️ Utility checks critical parameters of Tc-99m ECD: • Radiochemical purity (≥95%) • Free pertechnetate (≤2%) • Colloidal technetium (≤3%) • Stability: use…
110Tc-99m Exametazimetechnetium99m exametazimeTc-99m Exametazime Quality Checker — Technetium-99m Exametazime (HMPAO) for Brain and WBCs ℹ️ Utility checks critical parameters of Tc-99m HMPAO: • Radiochemical purity of lipophilic complex (≥80%) • Secondary complex (≤15%) • Free pertechn…
111AAS Aluminum Limit Testaas aluminum limit testUtility description: AAS Aluminum Limit Test AAS Aluminum Limit Test — Aluminum Limit Determination (AAS) ℹ️ Utility checks aluminum content using Atomic Absorption Spectrometry: • Limit: ≤2.
112AAS Dialysis Solution Metalsaas dialysis solution metalsUtility description: AAS Dialysis Solution Metals AAS Dialysis Solution Metals — Metal Control in Dialysis Solutions ℹ️ Utility checks electrolytes and toxic metals content: • Electrolytes: Ca, Mg, Na, K (composition control) • Toxic metals…
113AAS Elemental Impurities Class 1aas elemental impurities class1Utility description: AAS Elemental Impurities Class 1 AAS Elemental Impurities Class 1 — Class 1 Elements Control (ICH Q3D) ℹ️ Utility checks Class 1 elemental impurities according to ICH Q3D: • Cadmium (Cd) ≤0.
114AAS Heavy Metals Plant Materialaas heavy metals plant materialUtility description: AAS Heavy Metals Plant Material AAS Heavy Metals Plant Material — Heavy Metals in Plant Material ℹ️ Utility checks toxic elements content in medicinal plants: • Lead (Pb) ≤5.
115Capillary ID Galantaminecapillary id galantamineUtility description: Capillary ID Galantamine Capillary ID Galantamine — Galantamine Identification (CE) ℹ️ Utility checks capillary electrophoresis parameters for galantamine: • Migration time (comparison with standard) • Purity by peak ar…
116Mercury Analyzer Fish Oilmercury analyzer fish oilUtility description: Mercury Analyzer Fish Oil Mercury Analyzer Fish Oil — Analysis of Mercury and Heavy Metals in Fish Oil ℹ️ Utility checks critical safety parameters of fish oil: • Total Mercury: ≤100 ppb (0.
117Mercury Analyzer Water Hemodialysismercury analyzer water hemodialysisUtility description: Mercury Analyzer Water Hemodialysis Mercury Analyzer Water Hemodialysis — Quality Control of Hemodialysis Water ℹ️ Utility checks critical chemical purity parameters of hemodialysis water: • Total Mercury: ≤0.
118Polyethylene Glycol Impurity Checkerpolyethylene glycol impurity checkerUtility description: Polyethylene Glycol Impurity Checker Polyethylene Glycol Impurity Checker — Control of Polyethylene Glycol (PEG) Impurities ℹ️ Utility checks critical safety parameters of PEG: • Ethylene Glycol: ≤10 ppm • Diethylene Gl…
119Melting Pointmelting pointMelting Point Quality Checker — Control of Melting Point ℹ️ Utility checks compliance of melting point with pharmacopoeial requirements (Ph.
120OsmolalityosmolalityOsmolality Quality Checker — Control of Solution Osmolality ℹ️ Utility checks compliance of osmolality with specified limits (USP / Ph.
121Thermal Analysis DSC/TGAthermal analysis dsc tgaquality checkerThermal Analysis DSC/TGA Quality Checker — Thermal Analysis (DSC/TGA) ℹ️ Utility assesses thermal properties of pharmaceutical substances using Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA): • Melting Onset an…