EAEU Pharmacopoeia QC Suite
Пакет утилит по фармакопейным методам ЕАЭС: спецификации, растворение, микробиология, примеси и общие испытания.
47 Утилиты
EAEU pharmacopoeia
EAEU pharmacopoeia dissolution microbiology impurities specification
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 → EAEU Pharmacopoeia QC Suite → output.json → QA approval / audit trail
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| AntimicrobialPreservativeEffectivenessChecker | Antimicrobial Preservative Effectiveness | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| BCSClassifier | BCS | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| BioburdenChecker | Bioburden | EAEU pharmacopoeia, Sterile liquids | contrast media dialysis dissolution EAEU | |
| ChloridesChecker | Chlorides | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ContentUniformityChecker | Content Uniformity | EAEU pharmacopoeia | capsules dissolution EAEU impurities | |
| DissolutionApparatusPerformanceChecker | Dissolution Apparatus Performance | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| DissolutionF2Comparator | Dissolution F2 Comparator | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| DissolutionProfileChecker | Dissolution Profile | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| DoseUniformityChecker | Dose Uniformity | EAEU pharmacopoeia | capsules dissolution EAEU impurities | |
| DrugProductSpecificationChecker | Drug Product Specification | EAEU pharmacopoeia | capsules dissolution EAEU impurities | |
| ELISA_SpecificProteinChecker | ELISA Specific Protein | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| EndotoxinChecker | Endotoxin | EAEU pharmacopoeia, Sterile liquids | contrast media dialysis dissolution EAEU | |
| ExtractablesLeachablesRiskAssessor | Extractables Leachables Risk Assessor | EAEU pharmacopoeia | dissolution EAEU impurities infusions | |
| FlowCytometry_ViabilityChecker | Flow Cytometry Viability | EAEU pharmacopoeia | dissolution EAEU impurities infusions | |
| ForeignMatterChecker | Foreign Matter | EAEU pharmacopoeia | dissolution EAEU herbal impurities | |
| HeavyMetalsChecker | Heavy Metals | EAEU pharmacopoeia, Pharmacopoeial methods | dissolution EAEU heavy metals herbal | |
| ImpurityThresholdChecker | Impurity Threshold | EAEU pharmacopoeia, Herbal pharmacopoeia | ash BHP botanical dissolution | |
| IronChecker | Iron | EAEU pharmacopoeia | antibiotics dissolution EAEU impurities | |
| LossOnDryingChecker | Loss On Drying | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| MAT_PyrogenChecker | MAT Pyrogen | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| MeltingPointChecker | Melting Point | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| MethodValidationReporter | Method Validation Reporter | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| MicrobialEnumerationChecker | Microbial Enumeration | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| MonographDissolutionChecker | Monograph Dissolution | EAEU pharmacopoeia | capsules dissolution EAEU impurities | |
| OilParametersChecker | Oil Parameters | EAEU pharmacopoeia | dissolution EAEU herbal impurities | |
| pHChecker | p H | EAEU pharmacopoeia | dissolution EAEU impurities injectables | |
| ParticleSizeDistributionChecker | Particle Size Distribution | Dermal fillers, EAEU pharmacopoeia | dermal fillers dissolution EAEU endotoxins | |
| qPCR_ViralSafetyChecker | q PCR Viral Safety | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| rFC_EndotoxinChecker | r FC Endotoxin | EAEU pharmacopoeia | dissolution EAEU endotoxins impurities | |
| RelativeDensityChecker | Relative Density | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ResidualHostDNAChecker | Residual Host DNA | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ResidualHostProteinChecker | Residual Host Protein | EAEU pharmacopoeia | biologics dissolution EAEU impurities | |
| ResidualSolventsChecker | Residual Solvents | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ResidualSolventsCompliance | Residual Solvents Compliance | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| ResidueOnIgnitionChecker | Residue On Ignition | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| StabilityTrendAnalyzer | Stability Trend Analyzer | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| SterilityResultEvaluator | Sterility Result | EAEU pharmacopoeia, Sterile liquids | contrast media dialysis dissolution EAEU | |
| SubstanceSpecificationChecker | Substance Specification | EAEU pharmacopoeia | dissolution EAEU heavy metals impurities | |
| SulfatedAshChecker | Sulfated Ash | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| SulfatesChecker | Sulfates | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| TabletDisintegrationChecker | Tablet Disintegration | EAEU pharmacopoeia, Pharmacopoeial methods | capsules dissolution EAEU heavy metals | |
| TabletFriabilityChecker | Tablet Friability | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| TabletHardnessChecker | Tablet Hardness | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| TotalAshChecker | Total Ash | EAEU pharmacopoeia | dissolution EAEU herbal impurities | |
| UniformityOfMassChecker | Uniformity Of Mass | EAEU pharmacopoeia | capsules dissolution EAEU impurities | |
| WaterByDistillationChecker | Water By Distillation | EAEU pharmacopoeia | dissolution EAEU herbal impurities | |
| WaterContentKFChecker | Water Content KF | EAEU pharmacopoeia | dissolution EAEU impurities microbiology |
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.