Article: EAEU Pharmacopoeia QC Suite

Package for EAEU pharmacopoeial methods: specifications, dissolution, microbiology, impurities and general tests.

Package

EAEU 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	Antimicrobial Preservative Effectiveness	`AntimicrobialPreservativeEffectivenessChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
2	BCS	`BCSClassifier`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
3	Bioburden	`BioburdenChecker`	contrast media, dialysis, dissolution, EAEU, endotoxins
4	Chlorides	`ChloridesChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
5	Content Uniformity	`ContentUniformityChecker`	capsules, dissolution, EAEU, impurities, microbiology
6	Dissolution Apparatus Performance	`DissolutionApparatusPerformanceChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
7	Dissolution F2 Comparator	`DissolutionF2Comparator`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
8	Dissolution Profile	`DissolutionProfileChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
9	Dose Uniformity	`DoseUniformityChecker`	capsules, dissolution, EAEU, impurities, microbiology
10	Drug Product Specification	`DrugProductSpecificationChecker`	capsules, dissolution, EAEU, impurities, microbiology
11	ELISA Specific Protein	`ELISA_SpecificProteinChecker`	biologics, dissolution, EAEU, impurities, microbiology
12	Endotoxin	`EndotoxinChecker`	contrast media, dialysis, dissolution, EAEU, endotoxins
13	Extractables Leachables Risk Assessor	`ExtractablesLeachablesRiskAssessor`	dissolution, EAEU, impurities, infusions, injectables
14	Flow Cytometry Viability	`FlowCytometry_ViabilityChecker`	dissolution, EAEU, impurities, infusions, microbiology
15	Foreign Matter	`ForeignMatterChecker`	dissolution, EAEU, herbal, impurities, microbiology
16	Heavy Metals	`HeavyMetalsChecker`	dissolution, EAEU, heavy metals, herbal, impurities
17	Impurity Threshold	`ImpurityThresholdChecker`	ash, BHP, botanical, dissolution, EAEU
18	Iron	`IronChecker`	antibiotics, dissolution, EAEU, impurities, microbiology
19	Loss On Drying	`LossOnDryingChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
20	MAT Pyrogen	`MAT_PyrogenChecker`	biologics, dissolution, EAEU, impurities, microbiology
21	Melting Point	`MeltingPointChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
22	Method Validation Reporter	`MethodValidationReporter`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
23	Microbial Enumeration	`MicrobialEnumerationChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
24	Monograph Dissolution	`MonographDissolutionChecker`	capsules, dissolution, EAEU, impurities, microbiology
25	Oil Parameters	`OilParametersChecker`	dissolution, EAEU, herbal, impurities, microbiology
26	p H	`pHChecker`	dissolution, EAEU, impurities, injectables, microbiology
27	Particle Size Distribution	`ParticleSizeDistributionChecker`	dermal fillers, dissolution, EAEU, endotoxins, hyaluronic acid
28	q PCR Viral Safety	`qPCR_ViralSafetyChecker`	biologics, dissolution, EAEU, impurities, microbiology
29	r FC Endotoxin	`rFC_EndotoxinChecker`	dissolution, EAEU, endotoxins, impurities, microbiology
30	Relative Density	`RelativeDensityChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
31	Residual Host DNA	`ResidualHostDNAChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
32	Residual Host Protein	`ResidualHostProteinChecker`	biologics, dissolution, EAEU, impurities, microbiology
33	Residual Solvents	`ResidualSolventsChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
34	Residual Solvents Compliance	`ResidualSolventsCompliance`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
35	Residue On Ignition	`ResidueOnIgnitionChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
36	Stability Trend Analyzer	`StabilityTrendAnalyzer`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
37	Sterility Result	`SterilityResultEvaluator`	contrast media, dialysis, dissolution, EAEU, endotoxins
38	Substance Specification	`SubstanceSpecificationChecker`	dissolution, EAEU, heavy metals, impurities, microbiology
39	Sulfated Ash	`SulfatedAshChecker`	dissolution, EAEU, impurities, microbiology, minerals
40	Sulfates	`SulfatesChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
41	Tablet Disintegration	`TabletDisintegrationChecker`	capsules, dissolution, EAEU, heavy metals, impurities
42	Tablet Friability	`TabletFriabilityChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
43	Tablet Hardness	`TabletHardnessChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia
44	Total Ash	`TotalAshChecker`	dissolution, EAEU, herbal, impurities, microbiology
45	Uniformity Of Mass	`UniformityOfMassChecker`	capsules, dissolution, EAEU, impurities, microbiology
46	Water By Distillation	`WaterByDistillationChecker`	dissolution, EAEU, herbal, impurities, microbiology
47	Water Content KF	`WaterContentKFChecker`	dissolution, EAEU, impurities, microbiology, pharmacopoeia

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.

EAEU pharmacopoeia dissolution microbiology impurities specification

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	Antimicrobial Preservative Effectiveness	`antimicrobial preservative effectiveness checker`	Antimicrobial Preservative Effectiveness Checker — Preservative efficacy testing (Ph.
2	BCS	`bcsclassifier`	BCS Classifier — Biopharmaceutics Classification System assessment (ICH M9) ℹ️ The utility determines BCS class based on dose, solubility, and permeability.
3	Bioburden	`bioburden checker`	Bioburden Checker — Microbial enumeration assessment (Ph.
4	Chlorides	`chlorides checker`	Chlorides Checker — Chlorides content assessment (Ph.
5	Content Uniformity	`content uniformity checker`	Content Uniformity Checker — Content uniformity assessment (Ph.
6	Dissolution Apparatus Performance	`dissolution apparatus performance checker`	Dissolution Apparatus Performance Checker — Dissolution equipment performance verification (Ph.
7	Dissolution F2 Comparator	`dissolution f2 comparator`	Dissolution f2 Comparator — Dissolution profile comparison (FDA/EMA) ℹ️ The utility calculates the f2 similarity factor between test and reference dissolution profiles.
8	Dissolution Profile	`dissolution profile checker`	Dissolution Profile Checker — Dissolution profile verification (Ph.
9	Dose Uniformity	`dose uniformity checker`	Dose Uniformity Checker — Dose uniformity assessment (Ph.
10	Drug Product Specification	`drug product specification checker`	Drug Product Specification Checker — Finished product specification verification (Ph.
11	ELISA Specific Protein	`elisa specific protein checker`	ELISA Specific Protein Checker — Protein content verification (ICH Q6B) ℹ️ The utility verifies ELISA results: API, HCP, aggregates in biologics.
12	Endotoxin	`endotoxin checker`	Endotoxin Checker — Endotoxin assessment (Ph. Eur. 2.6.14) ℹ️ The utility verifies that endotoxin levels comply with European Pharmacopoeia requirements. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ For Water for Injections:…
13	Extractables Leachables Risk Assessor	`extractables leachables risk assessor`	Extractables & Leachables Risk Assessor — E&L risk screening (ICH Q3E) ℹ️ The utility assesses risk of extractables/leachables from packaging and components.
14	Flow Cytometry Viability	`flow cytometry viability checker`	Flow Cytometry Viability Checker — Cell viability and marker verification (Ph.
15	Foreign Matter	`foreign matter checker`	Foreign Matter Checker — Foreign matter verification in herbal materials (Ph.
16	Heavy Metals	`heavy metals checker`	Heavy Metals Checker — Контроль тяжёлых металлов (Ph.
17	Impurity Threshold	`impurity threshold checker`	Impurity Threshold Checker — Impurity control according to ICH Q3 ℹ️ The utility calculates impurity percentages relative to the main peak and compares them with ICH Q3A(R2) thresholds: • Reporting threshold: 0.
18	Iron	`iron checker`	Iron Checker — Iron content verification (Ph. Eur. 2.4.17) ℹ️ The utility verifies iron content in pharmaceutical substances. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ Iron is a catalytic impurity that accelerates API oxi…
19	Loss On Drying	`loss on drying checker`	Loss on Drying Checker — Loss on drying verification (Ph.
20	MAT Pyrogen	`mat pyrogen checker`	MAT Pyrogen Checker — Pyrogenicity assessment via Monocyte Activation Test (Ph.
21	Melting Point	`melting point checker`	Melting Point Checker — Melting point verification (Ph.
22	Method Validation Reporter	`method validation reporter`	Method Validation Reporter — Analytical method validation assessment (ICH Q2) ℹ️ The utility verifies key analytical method validation parameters.
23	Microbial Enumeration	`microbial enumeration checker`	Microbial Enumeration Checker — Total microbial count and pathogens (Ph.
24	Monograph Dissolution	`monograph dissolution checker`	Monograph Dissolution Checker — Dissolution profile verification per pharmacopoeial monograph (Ph.
25	Oil Parameters	`oil parameters checker`	Oil Parameters Checker — Pharmaceutical oil quality verification (Ph.
26	p H	`p hchecker`	pH Checker — pH verification for pharmaceutical solutions (Ph.
27	Particle Size Distribution	`particle size distribution checker`	Particle Size Distribution Checker — Particle Size Analysis (ISO 13485, Ph.
28	q PCR Viral Safety	`q pcr viral safety checker`	qPCR Viral Safety Checker — qPCR assay validation and interpretation (Ph.
29	r FC Endotoxin	`r fc endotoxin checker`	rFC Endotoxin Checker — Endotoxin testing via recombinant Factor C (Ph.
30	Relative Density	`relative density checker`	Relative Density Checker — Relative density verification (Ph.
31	Residual Host DNA	`residual host dnachecker`	Residual Solvents Checker — Residual solvent verification (ICH Q3C) ℹ️ The utility verifies residual organic solvents in APIs and drug products.
32	Residual Host Protein	`residual host protein checker`	Residual Host Protein Checker — Host Cell Protein (HCP) verification ℹ️ The utility verifies HCP levels in biologics (mAbs, recombinant proteins).
33	Residual Solvents	`residual solvents checker`	Residual Solvents Checker — Residual solvent verification (ICH Q3C) ℹ️ The utility verifies residual organic solvents in APIs and drug products.
34	Residual Solvents Compliance	`residual solvents compliance`	Residual Solvents Compliance — Residual solvent limit calculation (ICH Q3C) ℹ️ The utility calculates the acceptable residual solvent limit (ppm) based on PDE and daily dose.
35	Residue On Ignition	`residue on ignition checker`	Residue on Ignition Checker — Inorganic residue verification (Ph.
36	Stability Trend Analyzer	`stability trend analyzer`	Stability Trend Analyzer — Stability trend assessment (ICH Q1E) ℹ️ The utility fits a linear degradation model and predicts purity at 12 months.
37	Sterility Result	`sterility result evaluator`	Sterility Result Evaluator — Sterility test interpretation (Ph.
38	Substance Specification	`substance specification checker`	Substance Specification Checker — Comprehensive substance specification verification ℹ️ The utility checks key substance parameters: assay, impurities, heavy metals, residual solvents, loss on drying.
39	Sulfated Ash	`sulfated ash checker`	Sulfated Ash Checker — Sulfated ash verification (Ph.
40	Sulfates	`sulfates checker`	Sulfates Checker — Sulfates content verification (Ph.
41	Tablet Disintegration	`tablet disintegration checker`	Tablet Disintegration Checker — Проверка распадаемости таблеток и капсул (Ph.
42	Tablet Friability	`tablet friability checker`	Tablet Friability Checker — Tablet friability verification (Ph.
43	Tablet Hardness	`tablet hardness checker`	Tablet Hardness Checker — Tablet hardness verification (Ph.
44	Total Ash	`total ash checker`	Total Ash Checker — Total ash verification (Ph. Eur. 2.4.16) ℹ️ The utility verifies total ash content in herbal raw materials. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ High ash content → contamination with soil, sand, o…
45	Uniformity Of Mass	`uniformity of mass checker`	Uniformity of Mass Checker — Mass uniformity verification (Ph.
46	Water By Distillation	`water by distillation checker`	Water by Distillation Checker — Water content verification by distillation (Ph.
47	Water Content KF	`water content kfchecker`	Water Content KF Checker — Karl Fischer water content verification (Ph.