Инфекционистика
Пакет QC-утилит для инфекционистики: антибактериальные, противовирусные, противогрибковые и противопаразитарные продукты, микробиология, стерильность, эндотоксины, вирусная безопасность, вакцинные release-checks.
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
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| AbacavirSulfateQualityChecker | Abacavir Sulfate | BP monographs | API assay British Pharmacopoeia impurities | |
| AciclovirQualityChecker | Aciclovir | BP monographs | API assay British Pharmacopoeia impurities | |
| AcyclovirQualityChecker | Acyclovir | Global API expansion | antivirals API biologics dissolution | |
| AcyclovirImpurityChecker | Acyclovir Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| AlbendazoleQualityChecker | Albendazole | BP monographs | API assay British Pharmacopoeia impurities | |
| AmikacinQualityChecker | Amikacin | BP monographs | antibiotics API assay British Pharmacopoeia | |
| 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 | |
| AntibioticPotencyEvaluator | Antibiotic Potency | Pharmacopoeial methods | antibiotics heavy metals microbiology particulate contamination | |
| AntimicrobialPreservativeEffectivenessChecker | Antimicrobial Preservative Effectiveness | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ArtemetherLumefantrineQualityChecker | Artemether Lumefantrine | Global API expansion | antivirals API biologics dissolution | |
| ArtesunateQualityChecker | Artesunate | Global API expansion | antivirals API biologics dissolution | |
| AssayImpuritiesResultReviewer | Assay & Impurities Result | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| AssayImpurityHPLCQualityChecker | Assay & Impurity HPLC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| AtazanavirSulfateQualityChecker | Atazanavir Sulfate | BP monographs | API assay British Pharmacopoeia impurities | |
| AutomatedSterilityDetectionQualityChecker | Automated Sterility Detection | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| AzithromycinQualityChecker | Azithromycin | BP monographs | antibiotics API assay British Pharmacopoeia | |
| BacterialCountBioburdenChecker | Bacterial Count Bioburden | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| BacterialEndotoxinAndSterilityCombined_QualityChecker | Bacterial Endotoxin & Sterility Combined | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| 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 | |
| BatchReleaseJsonBuilder | Batch Release Json Builder | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| BictegravirEmtricitabineTenofovirAlafenamideQualityChecker | Bictegravir Emtricitabine Tenofovir Alafenamide | Global API expansion | antivirals API biologics dissolution | |
| BioburdenChecker | Bioburden | EAEU pharmacopoeia, Sterile liquids | contrast media dialysis dissolution EAEU | |
| BioburdenTrendChecker | Bioburden Trend | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| CapreomycinQualityChecker | Capreomycin | BP monographs | antibiotics API assay biologics | |
| CefaclorQualityChecker | Cefaclor | BP monographs | antibiotics API assay British Pharmacopoeia | |
| CefadroxilMonohydrateQualityChecker | Cefadroxil Monohydrate | BP monographs | antibiotics API assay British Pharmacopoeia | |
| CefalexinMonohydrateQualityChecker | Cefalexin Monohydrate | BP monographs | antibiotics API assay British Pharmacopoeia | |
| CefazolinSodiumQualityChecker | Cefazolin Sodium | BP monographs | API assay British Pharmacopoeia impurities | |
| CefepimeHydrochlorideMonohydrateQualityChecker | Cefepime Hydrochloride Monohydrate | BP monographs | API assay British Pharmacopoeia impurities | |
| CefiximeQualityChecker | Cefixime | BP monographs | API assay British Pharmacopoeia impurities | |
| CefoperazoneSodiumQualityChecker | Cefoperazone Sodium | BP monographs | API assay British Pharmacopoeia impurities | |
| CefotaximeSodiumQualityChecker | Cefotaxime Sodium | BP monographs | API assay British Pharmacopoeia impurities | |
| CefoxitinSodiumQualityChecker | Cefoxitin Sodium | BP monographs | API assay British Pharmacopoeia impurities | |
| CefpodoximeProxetilQualityChecker | Cefpodoxime Proxetil | BP monographs | API assay biologics British Pharmacopoeia | |
| CeftriaxoneQualityChecker | Ceftriaxone | Global API | antibiotics API assay biosimilars | |
| CeftriaxoneSodiumPurityChecker | Ceftriaxone Sodium Purity Checker | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis | Lumex QC URS & FS input.csv | |
| CefuroximeAxetilQualityChecker | Cefuroxime Axetil | BP monographs | API assay British Pharmacopoeia impurities | |
| CephalexinQualityChecker | Cephalexin | Global API expansion | antibiotics antivirals API biologics | |
| ChloramphenicolQualityChecker | Chloramphenicol | BP monographs | antibiotics API assay British Pharmacopoeia | |
| CiprofloxacinQualityChecker | Ciprofloxacin | BP monographs | antibiotics API assay British Pharmacopoeia | |
| CiprofloxacinImpurityChecker | Ciprofloxacin Impurity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| ClarithromycinQualityChecker | Clarithromycin | BP monographs | antibiotics API assay British Pharmacopoeia | |
| ClindamycinQualityChecker | Clindamycin | BP monographs | antibiotics API assay British Pharmacopoeia | |
| ClotrimazoleQualityChecker | Clotrimazole | BP monographs | API assay British Pharmacopoeia impurities | |
| ColdChainExcursionDecisionUtility | Cold Chain Excursion Decision | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| ColdChainShippingTemperatureAndMKT_QualityChecker | Cold Chain Shipping Temperature And MKT | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| DaclatasvirAssayChecker | Daclatasvir Assay Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| DapsoneQualityChecker | Dapsone | BP monographs | API assay British Pharmacopoeia impurities | |
| DaptomycinQualityChecker | Daptomycin | Global API expansion | antibiotics antivirals API biologics | |
| Dissolution_Profile_f2_Calculator | Dissolution Profile f2 Calculator | Pharmaceutical QC, Lumex, General QC, Dissolution, Dissolution and comparative profiles | Lumex QC URS & FS input.csv | |
| DissolutionProfileValidator | Dissolution Profile Validator | Pharmacopoeial methods | capsules dissolution heavy metals microbiology | |
| DolutegravirQualityChecker | Dolutegravir | Global API expansion | antivirals API biologics dissolution | |
| DoxycyclineQualityChecker | Doxycycline | BP monographs | antibiotics API assay British Pharmacopoeia | |
| EfavirenzQualityChecker | Efavirenz | Global API expansion | antivirals API biologics dissolution | |
| ElementalImpuritiesICPQualityChecker | Elemental Impurities ICP | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| EmtricitabineTenofovirDisoproxilFumarateQualityChecker | Emtricitabine Tenofovir Disoproxil Fumarate | Global API expansion | antivirals API biologics dissolution | |
| EndotoxinChecker | Endotoxin | EAEU pharmacopoeia, Sterile liquids | contrast media dialysis dissolution EAEU | |
| EndotoxinBiologicProductQualityChecker | Endotoxin Biologic Product | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| EndotoxinLALChecker | Endotoxin LAL | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| EndotoxinRiskPredictor | Endotoxin Risk Predictor | Pharmacopoeial methods | endotoxins heavy metals microbiology particulate contamination | |
| EndotoxinsAssessor | Endotoxins Assessor | Pharmacopoeial methods | endotoxins heavy metals infusions microbiology | |
| EntecavirQualityChecker | Entecavir | Global API | API assay biosimilars dissolution | |
| EnvironmentalMonitoringCleanroomQualityChecker | Environmental Monitoring Cleanroom | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| EnvironmentalMonitoringTrendUtility | Environmental Monitoring Trend | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| ErtapenemQualityChecker | Ertapenem | Global API expansion | antibiotics antivirals API biologics | |
| ErythromycinQualityChecker | Erythromycin | BP monographs | antibiotics API assay British Pharmacopoeia | |
| FluconazoleQualityChecker | Fluconazole | BP monographs | API assay British Pharmacopoeia impurities | |
| FluconazoleRelatedSubstancesChecker | Fluconazole Related Substances Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| FTIRIdentityQualityChecker | FTIR Identity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| GanciclovirQualityChecker | Ganciclovir | BP monographs | API assay British Pharmacopoeia impurities | |
| GlecaprevirPibrentasvirQualityChecker | Glecaprevir Pibrentasvir | Global API expansion | antivirals API biologics dissolution | |
| HeavyMetalsLimitTestQualityChecker | Heavy Metals Limit Test | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| HemagglutinationTiterChecker | Hemagglutination Titer | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| ImipenemCilastatinQualityChecker | Imipenem Cilastatin | Global API expansion | antibiotics antivirals API biologics | |
| InactivatedVaccineSafetyTest_QualityChecker | Inactivated Vaccine Safety Test | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| ItraconazoleQualityChecker | Itraconazole | BP monographs | API assay British Pharmacopoeia impurities | |
| KetoconazoleQualityChecker | Ketoconazole | BP monographs | API assay British Pharmacopoeia impurities | |
| LamivudineQualityChecker | Lamivudine | BP monographs | API assay British Pharmacopoeia impurities | |
| LCMSConfirmationQualityChecker | LC-MS Confirmation | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| LevofloxacinQualityChecker | Levofloxacin | BP monographs | API assay British Pharmacopoeia impurities | |
| LevofloxacinOpticalIsomerChecker | Levofloxacin Optical Isomer Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| LinezolidQualityChecker | Linezolid | Global API expansion | antibiotics antivirals API biologics | |
| LiveAttenuatedVaccineGeneticStability_QualityChecker | Live Attenuated Vaccine Genetic Stability | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| MAT_PyrogenChecker | MAT Pyrogen | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| MebendazoleQualityChecker | Mebendazole | Global API expansion | antivirals API biologics dissolution | |
| MeropenemTrihydrateQualityChecker | Meropenem Trihydrate | BP monographs | antibiotics API assay British Pharmacopoeia | |
| MetronidazoleQualityChecker | Metronidazole | BP monographs | API assay British Pharmacopoeia impurities | |
| MiconazoleQualityChecker | Miconazole | BP monographs | API assay British Pharmacopoeia impurities | |
| MicrobialEnumerationChecker | Microbial Enumeration | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| MicrobialEnumerationEvaluator | Microbial Enumeration | Pharmacopoeial methods | heavy metals microbiology particulate contamination Ph. Eur. | |
| 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 | |
| MinocyclineQualityChecker | Minocycline | Global API expansion | antibiotics antivirals API biologics | |
| mRNAVaccineIntegrityAndLNP_QualityChecker | mRNA Vaccine Integrity & LNP | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| MycoplasmaContaminationForecaster | Mycoplasma Contamination Forecaster | Pharmacopoeial methods | heavy metals microbiology particulate contamination Ph. Eur. | |
| NitrofurantoinQualityChecker | Nitrofurantoin | Global API | antibiotics API assay biosimilars | |
| OfloxacinOrnidazoleQualityChecker | Ofloxacin Ornidazole | Global API | antibiotics API assay biosimilars | |
| PiperacillinTazobactamQualityChecker | Piperacillin Tazobactam | Global API | antibiotics API assay biosimilars | |
| PosaconazoleQualityChecker | Posaconazole | Global API expansion | antivirals API biologics dissolution | |
| PyrogenTestRabbitMATQualityChecker | Pyrogen Test (Rabbit & MAT) | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| qPCR_ViralSafetyChecker | q PCR Viral Safety | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| RabiesVaccinePotencyAssayReviewer | Rabies Vaccine Potency Assay | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| RamanIdentityQualityChecker | Raman Identity | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ReplicationCompetentVirus_RCV_QualityChecker | Replication Competent Virus RCV | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| ResidualHostCellDNA_QualityChecker | Residual Host Cell DNA | Vaccine and biologics QC packages, Huvac — Human Vaccine QC Utilities, Huvac | Huvac human vaccines vaccination adjuvants | |
| ResidualHostCellDNAqPCRChecker | Residual Host Cell DNA qPCR | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| ResidualSolventsGCQualityChecker | Residual Solvents GC | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| RibavirinPurityChecker | Ribavirin Purity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| RifampicinQualityChecker | Rifampicin | Global API expansion | antibiotics antivirals API biologics | |
| SampleIdentityConsistencyChecker | Sample Identity Consistency | Molecular diagnostics QC packages, Liquid Biopsy, LiquidBiopsy | Liquid Biopsy жидкостная биопсия cfDNA ctDNA | |
| SofosbuvirImpurityProfiler | Sofosbuvir Impurity Profiler | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| SofosbuvirVelpatasvirQualityChecker | Sofosbuvir Velpatasvir | Global API expansion | antivirals API biologics dissolution | |
| SpecifiedMicroorganismsQualityChecker | Specified Microorganisms | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| StabilityConditionMonitoringQualityChecker | Stability Condition Monitoring | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| SterileReleaseChecklistUtility | Sterile Release Checklist | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| SterilityMycoplasmaReviewUtility | Sterility & Mycoplasma Review | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| SterilityTestReviewUtility | Sterility Test Review | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| TCID50InfectiousTiterCalculator | TCID50 Infectious Titer Calculator | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| TeicoplaninQualityChecker | Teicoplanin | Global API expansion | antibiotics antivirals API biologics | |
| TigecyclineQualityChecker | Tigecycline | Global API expansion | antibiotics antivirals API biologics | |
| UVVisIdentityAssayQualityChecker | UV-Vis Identity & Assay | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| VaccinePotencyTCID50_EID50_QualityChecker | Vaccine Potency TCID50/EID50 | Vaccine and biologics QC packages, Vet — Veterinary QC Utilities, Vet | Vet veterinary veterinary vaccines animal health | |
| ValacyclovirQualityChecker | Valacyclovir | Global API expansion | antivirals API biologics dissolution | |
| ValganciclovirQualityChecker | Valganciclovir | Global API expansion | antivirals API biologics dissolution | |
| VancomycinQualityChecker | Vancomycin | Global API expansion | antibiotics antivirals API biologics | |
| VoriconazoleQualityChecker | Voriconazole | BP monographs | API assay British Pharmacopoeia impurities | |
| WaterContentKFQualityChecker | Water Content KF | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| WaterMicrobiologicalChecker | Water Microbiological | Pharmacopoeial methods | biologics heavy metals microbiology particulate contamination | |
| WaterMicrobiologyQualityChecker | Water Microbiology | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS | |
| ZidovudineQualityChecker | Zidovudine | BP monographs | API assay British Pharmacopoeia impurities |
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.