Токсикология
Пакет QC-утилит для токсикологически значимых рисков: генотоксичные примеси, остаточные растворители, элементные примеси, тяжёлые металлы, ртуть, микотоксины, пестициды, extractables/leachables и деградационные примеси.
58 Утилиты
Risk / Toxicology / Impurities
Toxicology Impurities GenotoxicImpurities ResidualSolvents ElementalImpurities HeavyMetals
Почему выбирают FUZKK
✓ Меньше Excel-рисков
Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.
🔍 Готовность к аудиту
Готовность к аудиту (IQ/OQ): каждая утилита пакета поставляется с URS/FS, CSV-контрактом, JSON-выходом и структурой данных, пригодной для CSV/CSA, OQ/PQ и QA/QC review.
⏱ 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
Instrument / LIMS / ELN / MES → input.csv → Токсикология → output.json → QA approval / audit trail
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| AAS_Catalyst_Residues_Pd_Pt_Rh | AAS Catalyst Residues Pd Pt Rh | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, AAS / elemental impurities | Lumex QC URS & FS input.csv | |
| 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_Glass_Leachables_Test | AAS Glass Leachables Test | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, AAS / elemental impurities | Lumex QC URS & FS input.csv | |
| AAS_Heavy_Metals_Plant_Material | AAS Heavy Metals Plant Material | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, AAS / elemental impurities | Lumex QC URS & FS input.csv | |
| AAS_Nickel_Hydrogenated_Oils | AAS Nickel Hydrogenated Oils | 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 | |
| AcyclovirImpurityChecker | Acyclovir Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| AmoxicillinDegradationChecker | Amoxicillin Degradation Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| AssayImpurityHPLCQualityChecker | Assay & Impurity HPLC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| CiprofloxacinImpurityChecker | Ciprofloxacin Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| ClarityAndOpalescenceChecker | Clarity And Opalescence | Pharmacopoeial methods | antibiotics heavy metals microbiology particulate contamination | |
| ColorationEvaluator | Coloration | Pharmacopoeial methods | heavy metals microbiology particulate contamination Ph. Eur. | |
| DaclatasvirAssayChecker | Daclatasvir Assay Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| ElementalImpuritiesAssessor | Elemental Impurities Assessor | Pharmacopoeial methods | heavy metals impurities microbiology particulate contamination | |
| ElementalImpuritiesICPQualityChecker | Elemental Impurities ICP | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| EthanolAndMethanolValidator | Ethanol And Methanol Validator | Pharmacopoeial methods | heavy metals herbal microbiology particulate contamination | |
| EthyleneOxideAndDioxanChecker | Ethylene Oxide And Dioxan | Pharmacopoeial methods | heavy metals microbiology particulate contamination Ph. Eur. | |
| ExtractablesLeachablesRiskAssessor | Extractables Leachables Risk Assessor | EAEU pharmacopoeia | dissolution EAEU impurities infusions | |
| FluconazoleRelatedSubstancesChecker | Fluconazole Related Substances Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| Fluorat_Aflatoxin_Screener | Fluorat Aflatoxin Screener | Pharmaceutical QC, Lumex, Instrumental analysis, Fluorescence, Fluorescence / Fluorat methods | Lumex QC URS & FS input.csv | |
| Fluorat_Mycotoxins_Ochratoxin | Fluorat Mycotoxins Ochratoxin | Pharmaceutical QC, Lumex, Instrumental analysis, Fluorimetry, Fluorat / fluorimetry | Lumex QC URS & FS input.csv | |
| ForeignMatterChecker | Foreign Matter | EAEU pharmacopoeia | dissolution EAEU herbal impurities | |
| 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 | |
| HeavyMetalsChecker | Heavy Metals | EAEU pharmacopoeia, Pharmacopoeial methods | dissolution EAEU heavy metals herbal | |
| HeavyMetalsLimitTestQualityChecker | Heavy Metals Limit Test | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| IbuprofenRelatedSubstancesChecker | Ibuprofen Related Substances Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| LCMSConfirmationQualityChecker | LC-MS Confirmation | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| LevofloxacinOpticalIsomerChecker | Levofloxacin Optical Isomer Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| LosartanPotassiumImpurityChecker | Losartan Potassium Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| Mercury_Analyzer_Fish_Oil | Mercury Analyzer Fish Oil | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, Mercury analysis | Lumex QC URS & FS input.csv | |
| Mercury_Analyzer_Vaccine_Thimerosal | Mercury Analyzer Vaccine Thimerosal | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, Mercury analysis | Lumex QC URS & FS input.csv | |
| Mercury_Analyzer_Water_Hemodialysis | Mercury Analyzer Water Hemodialysis | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, Mercury analysis | Lumex QC URS & FS input.csv | |
| Mercury_Speciation_Methyl_vs_Inorganic | Mercury Speciation: Methyl vs Inorganic | Pharmaceutical QC, Lumex, Instrumental analysis, Elemental impurities, Mercury analysis / elemental impurities | Lumex QC URS & FS input.csv | |
| MethylparabenPropylparabenChecker | Methylparaben Propylparaben Checker | Pharmaceutical QC, Lumex, Excipients QC, Excipients / preservatives | Lumex QC URS & FS input.csv | |
| MicrowaveDigestionPrepQualityChecker | Microwave Digestion Prep | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| MycotoxinsInHerbsAssessor | Mycotoxins In Herbs Assessor | Pharmacopoeial methods | heavy metals herbal microbiology particulate contamination | |
| NMRStructureQualityChecker | NMR Structure | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ParacetamolImpurityChecker | Paracetamol Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| PesticidesAndAristolochicAcidsDetector | Pesticides And Aristolochic Acids Detector | Pharmacopoeial methods | heavy metals herbal microbiology particulate contamination | |
| PolyethyleneGlycolImpurityChecker | Polyethylene Glycol Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| Polysorbate80PeroxideChecker | Polysorbate 80 Peroxide Checker | Pharmaceutical QC, Lumex, Excipients QC, Excipients / preservatives | Lumex QC URS & FS input.csv | |
| RamanIdentityQualityChecker | Raman Identity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| RanitidineImpurityChecker | Ranitidine Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| ResidualFormaldehydeAndInactivant_QualityChecker | Residual Formaldehyde And Inactivant | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| ResidualInactivantChecker | Residual Inactivant | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| ResidualSolventsChecker | Residual Solvents | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ResidualSolventsBatchChecker | Residual Solvents Batch | Pharmacopoeial methods | heavy metals microbiology particulate contamination Ph. Eur. | |
| ResidualSolventsCompliance | Residual Solvents Compliance | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ResidualSolventsGCQualityChecker | Residual Solvents GC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ResidualSolventsValidator | Residual Solvents Validator | Pharmacopoeial methods | heavy metals microbiology particulate contamination Ph. Eur. | |
| 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 | |
| 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 |
Лицензирование и поддержка
Лицензирование и поддержка: пакет поставляется как набор QC-утилит для одной компании или производственной площадки, с возможной поддержкой пилота, LIMS/ELN/MES-интеграции и подготовки к валидации.