Стоматология и стоматологические материалы
Пакет QC-утилит для стоматологических лекарственных продуктов, средств для полости рта и стоматологических материалов: анестетики, антисептики, обезболивание/антибиотики, полимеры/минералы, смолы, бондинги, микробиология, стабильность и material QC.
Почему выбирают FUZKK
✓ Меньше Excel-рисков
Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.
🔍 Готовность к аудиту
Пакет показывает применимость существующих FUZKK-утилит к стоматологическим лекарственным продуктам и стоматологическим материалам без обещания отдельной dental-device validation logic.
⏱ Время лаборатории
Более быстрая проверка данных, ревью партии и структурированный JSON-результат для последующих систем.
🚀 Интеграция
Подходит для CSV, LIMS/ELN/MES и валидируемых лабораторных процессов.
Схема интеграции
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| AAS_Elemental_Impurities_Class1 | AAS Elemental Impurities Class 1 | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, AAS / elemental impurities | Lumex QC URS & FS input.csv | |
| AAS_Elemental_Impurities_Class2A | AAS Elemental Impurities Class 2A | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, AAS / elemental impurities | Lumex QC URS & FS input.csv | |
| AAS_Elemental_Impurities_Class2B | AAS/ICP-MS Elemental Impurities Class 2B | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, AAS / elemental impurities | Lumex QC URS & FS input.csv | |
| AmoxicillinQualityChecker | Amoxicillin | Global API | antibiotics API assay biosimilars | |
| AmoxicillinClavulanicAcidQualityChecker | Amoxicillin Clavulanic Acid | Global API | antibiotics API assay biosimilars | |
| AmoxicillinDegradationChecker | Amoxicillin Degradation Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| AnestheticLidocaineInFillerChecker | Anesthetic Lidocaine In Filler | Dermal fillers | dermal fillers endotoxins hyaluronic acid impurities | |
| AntimicrobialPreservativeEffectivenessChecker | Antimicrobial Preservative Effectiveness | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| AssayImpurityHPLCQualityChecker | Assay & Impurity HPLC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| AzithromycinQualityChecker | Azithromycin | BP monographs | antibiotics API assay British Pharmacopoeia | |
| BacterialEndotoxinsLALQualityChecker | Bacterial Endotoxins LAL | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| BacterialEndotoxinsRecombinantQualityChecker | Bacterial Endotoxins Recombinant | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| BenzalkoniumChlorideQualityChecker | Benzalkonium Chloride | Contraceptives | assay biologics contraceptives fixed-dose combinations | |
| BenzocaineQualityChecker | Benzocaine | BP monographs | API assay British Pharmacopoeia impurities | |
| BupivacaineQualityChecker | Bupivacaine | BP monographs | API assay British Pharmacopoeia impurities | |
| CalciumCarbonateQualityChecker | Calcium Carbonate | Vitamins and minerals | assay heavy metals impurities minerals | |
| CalciumGluconateQualityChecker | Calcium Gluconate | Vitamins and minerals | assay heavy metals impurities minerals | |
| CalciumHydroxylapatiteQualityChecker | Calcium Hydroxylapatite | Dermal fillers | dermal fillers endotoxins heavy metals hyaluronic acid | |
| ClarityAndOpalescenceChecker | Clarity And Opalescence | Pharmacopoeial methods | antibiotics heavy metals microbiology particulate contamination | |
| ClindamycinQualityChecker | Clindamycin | BP monographs | antibiotics API assay British Pharmacopoeia | |
| ColophonyQualityChecker | Colophony | Herbal pharmacopoeia | ash BHP botanical herbal | |
| ContentUniformityQualityChecker | Content Uniformity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| DensityRefractiveIndexQualityChecker | Density & Refractive Index | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| DisintegrationTabletCapsuleQualityChecker | Disintegration Tablet/Capsule | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| DissolutionApparatus12QualityChecker | Dissolution Apparatus 1 & 2 | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| Dissolution_Profile_f2_Calculator | Dissolution Profile f2 Calculator | Pharmaceutical QC, Lumex, General QC, Dissolution, Dissolution and comparative profiles | Lumex QC URS & FS input.csv | |
| ElementalImpuritiesICPQualityChecker | Elemental Impurities ICP | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| EnvironmentalMonitoringCleanroomQualityChecker | Environmental Monitoring Cleanroom | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ExtractablesLeachablesRiskAssessor | Extractables Leachables Risk Assessor | EAEU pharmacopoeia | dissolution EAEU impurities infusions | |
| FilterIntegrityTestQualityChecker | Filter Integrity Test | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| FTIRIdentityQualityChecker | FTIR Identity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| GCMSScreeningVolatileImpuritiesQualityChecker | GC-MS Screening Volatile Impurities | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| Genotoxic_Impurity_Screener_M7 | Genotoxic Impurity Screener M7 | Pharmaceutical QC, Lumex, Impurities, Risk assessment, Impurities / ICH M7 | Lumex QC URS & FS input.csv | |
| HeavyMetalsLimitTestQualityChecker | Heavy Metals Limit Test | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| IbuprofenQualityChecker | Ibuprofen | BP monographs | API assay British Pharmacopoeia impurities | |
| IbuprofenParacetamolQualityChecker | Ibuprofen Paracetamol | Global API | API assay biosimilars dissolution | |
| IbuprofenRelatedSubstancesChecker | Ibuprofen Related Substances Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| LossOnDryingQualityChecker | Loss On Drying | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| MeltingPointQualityChecker | Melting Point | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| MepivacaineHydrochlorideQualityChecker | Mepivacaine Hydrochloride | BP monographs | API assay British Pharmacopoeia impurities | |
| MetronidazoleQualityChecker | Metronidazole | BP monographs | API assay British Pharmacopoeia impurities | |
| MicrobialEnumerationTAMCTYMCQualityChecker | Microbial Enumeration (TAMC/TYMC) | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| MicrobialIdentificationSystemQualityChecker | Microbial Identification System | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| NitrousOxidePharmaceuticalQualityChecker | Nitrous Oxide Pharmaceutical | Medical gases | carbon dioxide impurities medical gases nitrogen | |
| OsmolalityQualityChecker | Osmolality | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ParacetamolQualityChecker | Paracetamol | BP monographs | API assay British Pharmacopoeia impurities | |
| ParacetamolImpurityChecker | Paracetamol Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| ParticleSizeDistributionChecker | Particle Size Distribution | Dermal fillers, EAEU pharmacopoeia | dermal fillers dissolution EAEU endotoxins | |
| pHConductivityWaterQualityChecker | pH & Conductivity Water | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| PolymethylMethacrylateQualityChecker | Polymethyl Methacrylate | Dermal fillers | dermal fillers endotoxins hyaluronic acid particles | |
| Polymorph_Screening_NIR_FTIR | Polymorph Screening NIR/FTIR | Pharmaceutical QC, Lumex, Instrumental analysis, NIR / PAT, NIR / PAT and spectroscopic QC | Lumex QC URS & FS input.csv | |
| PreservativeEfficacyValidator | Preservative Efficacy Validator | Pharmacopoeial methods, Sterile liquids | contrast media dialysis endotoxins heavy metals | |
| Preservatives_Combo_QC | Preservatives Combo QC | Pharmaceutical QC, Lumex, General QC, Instrumental analysis, General pharmaceutical QC | Lumex QC URS & FS input.csv | |
| PrilocaineQualityChecker | Prilocaine | BP monographs | API assay British Pharmacopoeia impurities | |
| RamanIdentityQualityChecker | Raman Identity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| RelativeDensityChecker | Relative Density | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ResidualSolventsGCQualityChecker | Residual Solvents GC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ResidueOnIgnitionChecker | Residue On Ignition | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| RheologyProfileValidator | Rheology Profile Validator | Dermal fillers | dermal fillers endotoxins hyaluronic acid injectables | |
| SamplePrepHomogenizationQualityChecker | Sample Prep Homogenization | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| SodiumBenzoatePreservativeChecker | Sodium Benzoate Preservative Checker | Pharmaceutical QC, Lumex, Excipients QC, Excipients / preservatives | Lumex QC URS & FS input.csv | |
| StabilityConditionMonitoringQualityChecker | Stability Condition Monitoring | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| Stability_Shelf_Life_Predictor | Stability Shelf Life Predictor | Pharmaceutical QC, Lumex, Stability, General QC, Stability and shelf-life modelling | Lumex QC URS & FS input.csv | |
| StabilityTrendAnalyzer | Stability Trend Analyzer | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| SterilityTestMembraneFiltrationQualityChecker | Sterility Test Membrane Filtration | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| SulfatedAshChecker | Sulfated Ash | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| TabletHardnessFriabilityQualityChecker | Tablet Hardness & Friability | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| TOCWaterQualityChecker | TOC Water | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| UVVisIdentityAssayQualityChecker | UV-Vis Identity & Assay | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ViscosityRheologyQualityChecker | Viscosity & Rheology | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| WaterActivityQualityChecker | Water Activity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| WaterContentKFQualityChecker | Water Content KF | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| WeightVariationTabletCapsuleQualityChecker | Weight Variation Tablet/Capsule | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| XRPDPolymorphQualityChecker | XRPD Polymorph | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS |
Лицензирование и поддержка
Пакет может использоваться как pre-proposal mapping для первичного контакта и как основа для пилота на конкретной лабораторной площадке.