European Pharmacopoeia QC Suite

Утилиты для общих фармакопейных методов и испытаний по европейскому регуляторному контуру.

52 Утилиты Pharmacopoeial methods Ph. Eur. pharmacopoeia microbiology residual solvents heavy metals particulate contamination
Статья

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 → European Pharmacopoeia QC Suite → output.json → QA approval / audit trail

Утилиты в пакете

УтилитаAPI / MonographКатегорииТеги
AntibioticPotencyEvaluator Antibiotic Potency Pharmacopoeial methods antibiotics heavy metals microbiology particulate contamination
BioassayValidityChecker Bioassay Validity Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
CellularProductsVerifier Cellular Products Verifier Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ClarityAndOpalescenceChecker Clarity And Opalescence Pharmacopoeial methods antibiotics heavy metals microbiology particulate contamination
CoagulationFactorsChecker Coagulation Factors Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ColorationEvaluator Coloration Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ConductivityValidator Conductivity Validator Pharmacopoeial methods, Sterile liquids contrast media dialysis endotoxins heavy metals
DissolutionProfileValidator Dissolution Profile Validator Pharmacopoeial methods capsules dissolution heavy metals microbiology
ElementalImpuritiesAssessor Elemental Impurities Assessor Pharmacopoeial methods heavy metals impurities microbiology particulate contamination
EndotoxinRiskPredictor Endotoxin Risk Predictor Pharmacopoeial methods endotoxins heavy metals microbiology particulate contamination
EndotoxinsAssessor Endotoxins Assessor Pharmacopoeial methods endotoxins heavy metals infusions microbiology
EssentialOilsQualityValidator Essential Oils Quality Validator Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
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.
FattyAcidsProfileValidator Fatty Acids Profile Validator Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
GasPurityVerifier Gas Purity Verifier Pharmacopoeial methods heavy metals medical gases microbiology particulate contamination
HeavyMetalsChecker Heavy Metals EAEU pharmacopoeia, Pharmacopoeial methods dissolution EAEU heavy metals herbal
HerbalAshAndResidueChecker Herbal Ash And Residue Pharmacopoeial methods heavy metals herbal microbiology particulate contamination
HerbalExtractsEvaluator Herbal Extracts Pharmacopoeial methods heavy metals herbal microbiology particulate contamination
HostCellResidualsAnalyzer Host Cell Residuals Analyzer Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ImmunoglobulinsAnalyzer Immunoglobulins Analyzer Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
InhalationParticleAssessor Inhalation Particle Assessor Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
LossOnDryingEvaluator Loss On Drying Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
MeltingPointVerifier Melting Point Verifier Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
MicrobialEnumerationEvaluator Microbial Enumeration Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
MicrobiologicalQualityChecker Microbiological Pharmacopoeial methods antibiotics biologics heavy metals herbal
MycoplasmaContaminationForecaster Mycoplasma Contamination Forecaster Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
MycotoxinsInHerbsAssessor Mycotoxins In Herbs Assessor Pharmacopoeial methods heavy metals herbal microbiology particulate contamination
pHComplianceValidator p H Compliance Validator Pharmacopoeial methods, Sterile liquids contrast media dialysis endotoxins heavy metals
ParticleTrendAnalyzer Particle Trend Analyzer Pharmacopoeial methods heavy metals infusions microbiology particulate contamination
ParticulateContaminationChecker Particulate Contamination Pharmacopoeial methods, Sterile liquids contrast media dialysis endotoxins heavy metals
PesticidesAndAristolochicAcidsDetector Pesticides And Aristolochic Acids Detector Pharmacopoeial methods heavy metals herbal microbiology particulate contamination
PotencyConfidenceIntervalCalculator Potency Confidence Interval Calculator Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
PowderFlowabilityAnalyzer Powder Flowability Analyzer Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
PreservativeEfficacyValidator Preservative Efficacy Validator Pharmacopoeial methods, Sterile liquids contrast media dialysis endotoxins heavy metals
PyrogenicityChecker Pyrogenicity Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ResidualSolventsBatchChecker Residual Solvents Batch Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ResidualSolventsValidator Residual Solvents Validator Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ResidualSulfonatesChecker Residual Sulfonates Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
SpecifiedMicroorganismsDetector Specified Microorganisms Detector Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
SulfatedAshEvaluator Sulfated Ash Pharmacopoeial methods heavy metals herbal microbiology particulate contamination
TabletDisintegrationChecker Tablet Disintegration EAEU pharmacopoeia, Pharmacopoeial methods capsules dissolution EAEU heavy metals
TOCInWaterForPharmaChecker TOC In Water For Pharma Pharmacopoeial methods, Sterile liquids contrast media dialysis endotoxins heavy metals
TotalAshInHerbalChecker Total Ash In Herbal Pharmacopoeial methods heavy metals herbal microbiology particulate contamination
UniformityOfDosageAssessor Uniformity Of Dosage Assessor Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
VaccineImpuritiesAssessor Vaccine Impurities Assessor Pharmacopoeial methods heavy metals impurities microbiology particulate contamination
VaccinePotencyAssessor Vaccine Potency Assessor Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ViralVaccineSafetyAssessor Viral Vaccine Safety Assessor Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
ViscosityAnalyzer Viscosity Analyzer Pharmacopoeial methods heavy metals microbiology particulate contamination Ph. Eur.
WaterContentByDistillationChecker Water Content By Distillation Pharmacopoeial methods heavy metals herbal microbiology particulate contamination
WaterMicrobiologicalChecker Water Microbiological Pharmacopoeial methods biologics heavy metals microbiology particulate contamination
WaterQualityValidator Water Quality Validator Pharmacopoeial methods endotoxins heavy metals microbiology particulate contamination

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.