Article: European Pharmacopoeia QC Suite

Utilities for general pharmacopoeial methods and tests in the European regulatory context.

Package

European Pharmacopoeia

Why choose FUZKK Utilities?

✅ Replace Excel

No hidden formulas or accidental edits. Deterministic logic, version control and reproducible results.

🔍 Audit-ready (IQ/OQ)

Each utility is supplied with URS & FS templates. This accelerates validation preparation and inspections.

⏱ Save QC time

Automate checks, calculations and reporting. The team focuses on deviations and scientific assessment rather than formatting.

🚀 Fast deployment

CSV input and JSON output allow integration without building heavy custom LIMS modules from scratch.

Integration workflow

LIMS / ELN / CSV export -> FUZKK utility -> output.json -> QMS / eDMS / batch release

The utilities read CSV input and generate structured JSON output suitable for automated batch release, QA/QC review and LIMS/ELN/MES integration.

Utilities in this package

#	API / product	Utility	Key checks
1	Antibiotic Potency	`AntibioticPotencyEvaluator`	antibiotics, heavy metals, microbiology, particulate contamination, Ph. Eur.
2	Bioassay Validity	`BioassayValidityChecker`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
3	Cellular Products Verifier	`CellularProductsVerifier`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
4	Clarity And Opalescence	`ClarityAndOpalescenceChecker`	antibiotics, heavy metals, microbiology, particulate contamination, Ph. Eur.
5	Coagulation Factors	`CoagulationFactorsChecker`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
6	Coloration	`ColorationEvaluator`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
7	Conductivity Validator	`ConductivityValidator`	contrast media, dialysis, endotoxins, heavy metals, impurities
8	Dissolution Profile Validator	`DissolutionProfileValidator`	capsules, dissolution, heavy metals, microbiology, particulate contamination
9	Elemental Impurities Assessor	`ElementalImpuritiesAssessor`	heavy metals, impurities, microbiology, particulate contamination, Ph. Eur.
10	Endotoxin Risk Predictor	`EndotoxinRiskPredictor`	endotoxins, heavy metals, microbiology, particulate contamination, Ph. Eur.
11	Endotoxins Assessor	`EndotoxinsAssessor`	endotoxins, heavy metals, infusions, microbiology, particulate contamination
12	Essential Oils Quality Validator	`EssentialOilsQualityValidator`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
13	Ethanol And Methanol Validator	`EthanolAndMethanolValidator`	heavy metals, herbal, microbiology, particulate contamination, Ph. Eur.
14	Ethylene Oxide And Dioxan	`EthyleneOxideAndDioxanChecker`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
15	Fatty Acids Profile Validator	`FattyAcidsProfileValidator`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
16	Gas Purity Verifier	`GasPurityVerifier`	heavy metals, medical gases, microbiology, particulate contamination, Ph. Eur.
17	Heavy Metals	`HeavyMetalsChecker`	dissolution, EAEU, heavy metals, herbal, impurities
18	Herbal Ash And Residue	`HerbalAshAndResidueChecker`	heavy metals, herbal, microbiology, particulate contamination, Ph. Eur.
19	Herbal Extracts	`HerbalExtractsEvaluator`	heavy metals, herbal, microbiology, particulate contamination, Ph. Eur.
20	Host Cell Residuals Analyzer	`HostCellResidualsAnalyzer`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
21	Immunoglobulins Analyzer	`ImmunoglobulinsAnalyzer`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
22	Inhalation Particle Assessor	`InhalationParticleAssessor`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
23	Loss On Drying	`LossOnDryingEvaluator`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
24	Melting Point Verifier	`MeltingPointVerifier`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
25	Microbial Enumeration	`MicrobialEnumerationEvaluator`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
26	Microbiological	`MicrobiologicalQualityChecker`	antibiotics, biologics, heavy metals, herbal, microbiology
27	Mycoplasma Contamination Forecaster	`MycoplasmaContaminationForecaster`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
28	Mycotoxins In Herbs Assessor	`MycotoxinsInHerbsAssessor`	heavy metals, herbal, microbiology, particulate contamination, Ph. Eur.
29	p H Compliance Validator	`pHComplianceValidator`	contrast media, dialysis, endotoxins, heavy metals, infusions
30	Particle Trend Analyzer	`ParticleTrendAnalyzer`	heavy metals, infusions, microbiology, particulate contamination, Ph. Eur.
31	Particulate Contamination	`ParticulateContaminationChecker`	contrast media, dialysis, endotoxins, heavy metals, infusions
32	Pesticides And Aristolochic Acids Detector	`PesticidesAndAristolochicAcidsDetector`	heavy metals, herbal, microbiology, particulate contamination, Ph. Eur.
33	Potency Confidence Interval Calculator	`PotencyConfidenceIntervalCalculator`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
34	Powder Flowability Analyzer	`PowderFlowabilityAnalyzer`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
35	Preservative Efficacy Validator	`PreservativeEfficacyValidator`	contrast media, dialysis, endotoxins, heavy metals, infusions
36	Pyrogenicity	`PyrogenicityChecker`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
37	Residual Solvents Batch	`ResidualSolventsBatchChecker`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
38	Residual Solvents Validator	`ResidualSolventsValidator`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
39	Residual Sulfonates	`ResidualSulfonatesChecker`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
40	Specified Microorganisms Detector	`SpecifiedMicroorganismsDetector`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
41	Sulfated Ash	`SulfatedAshEvaluator`	heavy metals, herbal, microbiology, particulate contamination, Ph. Eur.
42	Tablet Disintegration	`TabletDisintegrationChecker`	capsules, dissolution, EAEU, heavy metals, impurities
43	TOC In Water For Pharma	`TOCInWaterForPharmaChecker`	contrast media, dialysis, endotoxins, heavy metals, infusions
44	Total Ash In Herbal	`TotalAshInHerbalChecker`	heavy metals, herbal, microbiology, particulate contamination, Ph. Eur.
45	Uniformity Of Dosage Assessor	`UniformityOfDosageAssessor`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
46	Vaccine Impurities Assessor	`VaccineImpuritiesAssessor`	heavy metals, impurities, microbiology, particulate contamination, Ph. Eur.
47	Vaccine Potency Assessor	`VaccinePotencyAssessor`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
48	Viral Vaccine Safety Assessor	`ViralVaccineSafetyAssessor`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
49	Viscosity Analyzer	`ViscosityAnalyzer`	heavy metals, microbiology, particulate contamination, Ph. Eur., pharmacopoeia
50	Water Content By Distillation	`WaterContentByDistillationChecker`	heavy metals, herbal, microbiology, particulate contamination, Ph. Eur.
51	Water Microbiological	`WaterMicrobiologicalChecker`	biologics, heavy metals, microbiology, particulate contamination, Ph. Eur.
52	Water Quality Validator	`WaterQualityValidator`	endotoxins, heavy metals, microbiology, particulate contamination, Ph. Eur.

Package positioning

The package is a marketing and technical selection. It is suitable for the first discussion with QC, portfolio coverage assessment, pilot scoping and integration planning.

Ph. Eur. pharmacopoeia microbiology residual solvents heavy metals particulate contamination

Licensing & support

License is granted to one pharmaceutical company or manufacturing site, with no redistribution rights.
Utilities are provided “as is”; validation is performed by the client using URS & FS / IQ/OQ templates.
Integration support is available for LIMS/ELN/MES, pilot preparation and CSV/JSON workflow clarification.
No public price is shown: the commercial proposal depends on package scope, number of sites, delivery model and support level.

Questions? Need a QC demo or pilot?👉 Representative — FUZKK Pharma Utilities

Open package in the portal

Utilities and checked parameters

#	API / product	Utility	Key checks
1	Antibiotic Potency	`antibiotic potency evaluator`	Antibiotic Potency Evaluator — Оценка активности антибиотиков (Ph.
2	Bioassay Validity	`bioassay validity checker`	Bioassay Validity Checker — Проверка валидности биологического испытания (Ph.
3	Cellular Products Verifier	`cellular products verifier`	Cellular Products Verifier — Проверка клеточных продуктов (Ph.
4	Clarity And Opalescence	`clarity and opalescence checker`	Clarity and Opalescence Checker — Проверка прозрачности и опалесценции (Ph.
5	Coagulation Factors	`coagulation factors checker`	Coagulation Factors Checker — Проверка активности факторов свёртывания (Ph.
6	Coloration	`coloration evaluator`	Coloration Evaluator — Оценка степени окраски растворов (Ph.
7	Conductivity Validator	`conductivity validator`	Conductivity Validator — Проверка электропроводности воды (Ph.
8	Dissolution Profile Validator	`dissolution profile validator`	Dissolution Profile Validator — Проверка профиля растворения (Ph.
9	Elemental Impurities Assessor	`elemental impurities assessor`	Elemental Impurities Assessor — Оценка элементных примесей (Ph.
10	Endotoxin Risk Predictor	`endotoxin risk predictor`	Project description
11	Endotoxins Assessor	`endotoxins assessor`	Endotoxins Assessor — Проверка содержания бактериальных эндотоксинов (Ph.
12	Essential Oils Quality Validator	`essential oils quality validator`	Essential Oils Quality Validator — Проверка качества эфирных масел (Ph.
13	Ethanol And Methanol Validator	`ethanol and methanol validator`	Ethanol and Methanol Validator — Проверка содержания спиртов (Ph.
14	Ethylene Oxide And Dioxan	`ethylene oxide and dioxan checker`	Ethylene Oxide and Dioxan Checker — Контроль этиленоксида и диоксана (Ph.
15	Fatty Acids Profile Validator	`fatty acids profile validator`	Fatty Acids Profile Validator — Анализ профиля жирных кислот (Ph.
16	Gas Purity Verifier	`gas purity verifier`	Gas Purity Verifier — Проверка чистоты медицинских газов (Ph.
17	Heavy Metals	`heavy metals checker`	Heavy Metals Checker — Контроль тяжёлых металлов (Ph.
18	Herbal Ash And Residue	`herbal ash and residue checker`	Herbal Ash and Residue Checker — Анализ растительного сырья (Ph.
19	Herbal Extracts	`herbal extracts evaluator`	Herbal Extracts Evaluator — Оценка экстрактов растительного сырья (Ph.
20	Host Cell Residuals Analyzer	`host cell residuals analyzer`	Project description
21	Immunoglobulins Analyzer	`immunoglobulins analyzer`	Immunoglobulins Analyzer — Анализ активности иммуноглобулинов (Ph.
22	Inhalation Particle Assessor	`inhalation particle assessor`	Inhalation Particle Assessor — Оценка аэродинамических характеристик ингаляций (Ph.
23	Loss On Drying	`loss on drying evaluator`	Loss On Drying Evaluator — Оценка потерь при высушивании (Ph.
24	Melting Point Verifier	`melting point verifier`	Melting Point Verifier — Проверка температуры плавления (Ph.
25	Microbial Enumeration	`microbial enumeration evaluator`	Project description
26	Microbiological	`microbiological`	Microbiological Quality Checker — Проверка микробиологического качества (Ph.
27	Mycoplasma Contamination Forecaster	`mycoplasma contamination forecaster`	Project description
28	Mycotoxins In Herbs Assessor	`mycotoxins in herbs assessor`	Mycotoxins in Herbs Assessor — Оценка микотоксинов в растительном сырье (Ph.
29	p H Compliance Validator	`p hcompliance validator`	pH Compliance Validator — Проверка соответствия pH (Ph.
30	Particle Trend Analyzer	`particle trend analyzer`	Particle Trend Analyzer — Анализ трендов частиц (Ph.
31	Particulate Contamination	`particulate contamination checker`	Particulate Contamination Checker — Контроль загрязнения частицами (Ph.
32	Pesticides And Aristolochic Acids Detector	`pesticides and aristolochic acids detector`	Pesticides and Aristolochic Acids Detector — Контроль загрязнителей в растительном сырье (Ph.
33	Potency Confidence Interval Calculator	`potency confidence interval calculator`	Potency Confidence Interval Calculator — Расчёт доверительного интервала активности (Ph.
34	Powder Flowability Analyzer	`powder flowability analyzer`	Powder Flowability Analyzer — Анализ сыпучести порошков (Ph.
35	Preservative Efficacy Validator	`preservative efficacy validator`	Preservative Efficacy Validator — Проверка эффективности консервантов (Ph.
36	Pyrogenicity	`pyrogenicity checker`	Project description
37	Residual Solvents Batch	`residual solvents batch checker`	Residual Solvents Batch Checker — Контроль остаточных растворителей в партии (Ph.
38	Residual Solvents Validator	`residual solvents validator`	Residual Solvents Validator — Контроль остаточных растворителей (Ph.
39	Residual Sulfonates	`residual sulfonates checker`	Residual Sulfonates Checker — Контроль остаточных сульфонатов (Ph.
40	Specified Microorganisms Detector	`specified microorganisms detector`	Project description
41	Sulfated Ash	`sulfated ash evaluator`	Sulfated Ash Evaluator — Оценка сульфатной золы (Ph.
42	Tablet Disintegration	`tablet disintegration checker`	Tablet Disintegration Checker — Проверка распадаемости таблеток и капсул (Ph.
43	TOC In Water For Pharma	`tocin water for pharma checker`	TOC in Water for Pharma Checker — Проверка TOC в воде (Ph.
44	Total Ash In Herbal	`total ash in herbal checker`	Total Ash in Herbal Checker — Контроль общей золы в растительном сырье (Ph.
45	Uniformity Of Dosage Assessor	`uniformity of dosage assessor`	Uniformity of Dosage Assessor — Проверка равномерности доз (Ph.
46	Vaccine Impurities Assessor	`vaccine impurities assessor`	Vaccine Impurities Assessor — Оценка примесей в полисахаридных вакцинах (Ph.
47	Vaccine Potency Assessor	`vaccine potency assessor`	Vaccine Potency Assessor — Оценка активности вакцин (Ph.
48	Viral Vaccine Safety Assessor	`viral vaccine safety assessor`	Project description
49	Viscosity Analyzer	`viscosity analyzer`	Viscosity Analyzer — Анализ вязкости (Ph. Eur. 2.2.8–2.2.10, 2.2.49) ℹ️ Утилита проверяет соответствие вязкости требованиям Европейской фармакопеи. ℹ️ Не использует машинное обучение — только правила. Использование: ViscosityAnalyzer.exe →…
50	Water Content By Distillation	`water content by distillation checker`	Water Content by Distillation Checker — Проверка содержания воды (Ph.
51	Water Microbiological	`water microbiological checker`	Water Microbiological Checker — Микробиологический контроль воды (Ph.
52	Water Quality Validator	`water quality validator`	Water Quality Validator — Контроль химических параметров воды (Ph.