Infectious Diseases QC Suite: QC Utility Fit Map

Standard article for the Infectious Diseases QC Suite package: 133 existing FUZKK utilities grouped by QC workflows.

Infectious Diseases QC Suite: QC Utility Fit Map

This package highlights existing FUZKK utilities that fit anti-infective medicinal products, microbiological control, sterile release, endotoxins, viral safety and vaccine release checks.

Standard article for a new FUZKK portal package. The mapping uses existing utility IDs only; no new utility DTOs are added by this JSON.

Utilities

133

Coverage groups

Type

Pre-Proposal Fit Map

The package does not claim that every utility is required for every manufacturer. It is a pre-proposal utility fit map: an initial map of existing deterministic FUZKK QC tools that may be relevant for this domain.

Coverage groups

Antibacterial and antibiotic productsAntifungal and antiparasitic productsAntiviral products and viral safetyGeneral analytical releaseMicrobiology, sterility and endotoxinsVaccines and infectious-titer controls

Utility list

Group	Utility	Fit
Antibacterial and antibiotic products	Amoxicillin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Amoxicillin Clavulanic Acid Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	AmoxicillinDegradationChecker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
General analytical release	Amikacin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Azithromycin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Capreomycin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefaclor Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefadroxil Monohydrate Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefalexin Monohydrate Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefazolin Sodium Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefepime Hydrochloride Monohydrate Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefixime Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefoperazone Sodium Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefotaxime Sodium Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefoxitin Sodium Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefpodoxime Proxetil Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Ceftriaxone Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	CeftriaxoneSodiumPurityChecker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Cefuroxime Axetil Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
General analytical release	Cephalexin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Chloramphenicol Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Ciprofloxacin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	CiprofloxacinImpurityChecker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Clarithromycin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Clindamycin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Dapsone Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Daptomycin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Doxycycline Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Erythromycin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Ertapenem Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Imipenem Cilastatin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Linezolid Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Meropenem Trihydrate Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Metronidazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Minocycline Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Nitrofurantoin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Ofloxacin Ornidazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Piperacillin Tazobactam Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Rifampicin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Teicoplanin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Tigecycline Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Vancomycin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	Levofloxacin Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antibacterial and antibiotic products	LevofloxacinOpticalIsomerChecker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Abacavir Sulfate Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Aciclovir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Acyclovir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	AcyclovirImpurityChecker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Albendazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Artemether Lumefantrine Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Artesunate Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Atazanavir Sulfate Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Bictegravir Emtricitabine Tenofovir Alafenamide Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Clotrimazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	DaclatasvirAssayChecker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Dolutegravir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Efavirenz Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Emtricitabine Tenofovir Disoproxil Fumarate Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Entecavir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Fluconazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	FluconazoleRelatedSubstancesChecker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Ganciclovir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Glecaprevir Pibrentasvir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Itraconazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Ketoconazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Lamivudine Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Mebendazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Miconazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Posaconazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	RibavirinPurityChecker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	SofosbuvirImpurityProfiler	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Sofosbuvir Velpatasvir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Valacyclovir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Valganciclovir Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antifungal and antiparasitic products	Voriconazole Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Antiviral products and viral safety	Zidovudine Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
General analytical release	Antibiotic Potency Evaluator	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Microbiology, sterility and endotoxins	Antimicrobial Preservative Effectiveness Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Microbiology, sterility and endotoxins	Automated Sterility Detection Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
Microbiology, sterility and endotoxins	Bacterial Endotoxins LAL Quality Checker	Existing deterministic QC utility mapped to infectious-disease products, microbiology, sterility, endotoxin or vaccine-release workflows.
+ 53 additional mapped utilities are included in the package metadata and utility table.

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 and checked parameters

#	API / product	Utility	Key checks
1	Amoxicillin	`amoxicillin`	Amoxicillin Quality Checker — Antibiotic (Penicillin) (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, polymers (allergy), specific impurities, crystallinity. ℹ️ Does not use machine learning — rule-based…
2	Amoxicillin Clavulanic Acid	`amoxicillin clavulanic acid`	Amoxicillin Clavulanic Acid Quality Checker — Combined Antibiotic (Ph.
3	Amoxicillin Degradation Checker	`amoxicillin degradation checker`	Utility description: Amoxicillin Degradation Checker Amoxicillin Degradation Checker — Amoxicillin Degradation Product Control ℹ️ Utility checks critical stability parameters of amoxicillin: • Assay (95.
4	Amikacin	`amikacin`	Amikacin Quality Checker — Amikacin quality assessment (BP/Ph.
5	Azithromycin	`azithromycin`	Azithromycin Quality Checker — Azithromycin quality assessment (BP/Ph.
6	Capreomycin	`capreomycin`	Capreomycin Quality Checker — Capreomycin quality assessment (BP/Ph.
7	Cefaclor	`cefaclor`	Cefaclor Quality Checker — Cefaclor quality assessment (BP/Ph.
8	Cefadroxil Monohydrate	`cefadroxil monohydrate`	Cefadroxil Monohydrate Quality Checker — Cefadroxil monohydrate quality assessment (BP/Ph.
9	Cefalexin Monohydrate	`cefalexin monohydrate`	Cefalexin Monohydrate Quality Checker — Cefalexin monohydrate quality assessment (BP/Ph.
10	Cefazolin Sodium	`cefazolin sodium`	Cefazolin Sodium Quality Checker — Cefazolin sodium quality assessment (BP/Ph.
11	Cefepime Hydrochloride Monohydrate	`cefepime hydrochloride monohydrate`	Cefepime Hydrochloride Monohydrate Quality Checker — Cefepime hydrochloride monohydrate quality assessment (BP/Ph.
12	Cefixime	`cefixime`	Cefixime Quality Checker — Cefixime quality assessment (BP/Ph.
13	Cefoperazone Sodium	`cefoperazone sodium`	Cefoperazone Sodium Quality Checker — Cefoperazone sodium quality assessment (BP/Ph.
14	Cefotaxime Sodium	`cefotaxime sodium`	Cefotaxime Sodium Quality Checker — Cefotaxime sodium quality assessment (BP/Ph.
15	Cefoxitin Sodium	`cefoxitin sodium`	Cefoxitin Sodium Quality Checker — Cefoxitin sodium quality assessment (BP/Ph.
16	Cefpodoxime Proxetil	`cefpodoxime proxetil`	Cefpodoxime Proxetil Quality Checker — Cefpodoxime proxetil quality assessment (BP/Ph.
17	Ceftriaxone	`ceftriaxone`	Ceftriaxone Quality Checker — 3rd Generation Cephalosporin (Ph.
18	Ceftriaxone Sodium Purity Checker	`ceftriaxone sodium purity checker`	Utility description: Ceftriaxone Sodium Purity Checker Ceftriaxone Sodium Purity Checker — Ceftriaxone Sodium Purity Control ℹ️ Utility checks critical quality parameters of ceftriaxone sodium: • Assay (96.
19	Cefuroxime Axetil	`cefuroxime axetil`	Cefuroxime Axetil Quality Checker — Cefuroxime axetil quality assessment (BP/Ph.
20	Cephalexin	`cephalexin`	Cephalexin Quality Checker — Cephalosporin Antibiotic (Ph. Eur., USP) ℹ️ The utility checks assay, polymers, related substances, pH, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITI…
21	Chloramphenicol	`chloramphenicol`	Chloramphenicol Quality Checker — Chloramphenicol quality assessment (BP/Ph.
22	Ciprofloxacin	`ciprofloxacin`	Ciprofloxacin Quality Checker — Ciprofloxacin quality assessment (BP/Ph.
23	Ciprofloxacin Impurity Checker	`ciprofloxacin impurity checker`	Utility description: Ciprofloxacin Impurity Checker Ciprofloxacin Impurity Checker — Ciprofloxacin Impurity Control ℹ️ Utility checks critical quality parameters of ciprofloxacin: • Assay (98.
24	Clarithromycin	`clarithromycin`	Clarithromycin Quality Checker — Clarithromycin quality assessment (BP/Ph.
25	Clindamycin	`clindamycin`	Clindamycin Quality Checker — Clindamycin quality assessment (BP/Ph.
26	Dapsone	`dapsone`	Dapsone Quality Checker — Dapsone quality assessment (Ph. Eur. 0391) ℹ️ The utility verifies that key parameters of dapsone comply with European Pharmacopoeia requirements. ℹ️ Does not use machine learning — rule-based l…
27	Daptomycin	`daptomycin`	Daptomycin Quality Checker — Lipopeptide Antibiotic (Ph. Eur., USP) ℹ️ The utility checks A10 content, peptide profile, sterility, endotoxins, particulates. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CR…
28	Doxycycline	`doxycycline`	Doxycycline Quality Checker — Doxycycline quality assessment (BP/Ph.
29	Erythromycin	`erythromycin`	Erythromycin Quality Checker — Erythromycin quality assessment (Ph.
30	Ertapenem	`ertapenem`	Ertapenem Quality Checker — Carbapenem Antibiotic (Ph. Eur., USP) ℹ️ The utility checks assay, polymers, deamidated impurity, sterility, endotoxins. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!…
31	Imipenem Cilastatin	`imipenem cilastatin`	Imipenem Cilastatin Quality Checker — Carbapenem Antibiotic (Ph.
32	Linezolid	`linezolid`	Linezolid Quality Checker — Antibiotic (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized/hydrolysis impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic on…
33	Meropenem Trihydrate	`meropenem trihydrate`	Meropenem Trihydrate Quality Checker — Meropenem trihydrate quality assessment (BP/Ph.
34	Metronidazole	`metronidazole`	Metronidazole Quality Checker — Metronidazole quality assessment (Ph.
35	Minocycline	`minocycline`	Minocycline Quality Checker — Antibiotic (Ph. Eur., USP) ℹ️ The utility checks assay, epi-minocycline (epimerization), toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only.…
36	Nitrofurantoin	`nitrofurantoin`	Nitrofurantoin Quality Checker — Antibacterial Agent (Ph. Eur., USP) ℹ️ The utility checks assay, impurities (hydrolysis), DMF, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!…
37	Ofloxacin Ornidazole	`ofloxacin ornidazole`	Ofloxacin Ornidazole Quality Checker — Combo Antibiotic/Antiprotozoal ℹ️ The utility checks content of both APIs, nitro-impurities, synchronous dissolution.
38	Piperacillin Tazobactam	`piperacillin tazobactam`	Piperacillin Tazobactam Quality Checker — Combo Antibiotic (Injections) (Ph.
39	Rifampicin	`rifampicin`	Rifampicin Quality Checker — Antitubercular Antibiotic (Ph. Eur., USP) ℹ️ The utility checks assay, oxidized forms (quinones), methanol/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based log…
40	Teicoplanin	`teicoplanin`	Teicoplanin Quality Checker — Glycopeptide Antibiotic (Ph. Eur., USP) ℹ️ The utility checks factor profile (T2-1, T2-2, T2-3), endotoxins, sterility, arsenic. ℹ️ Does not use machine learning — rule-based logic only. ⚠️…
41	Tigecycline	`tigecycline`	Tigecycline Quality Checker — Glycylcycline Antibiotic (Ph. Eur., USP) ️ The utility checks epi-tigecycline, anhydro-tigecycline, solution color, endotoxins, sterility. ℹ️ Does not use machine learning — rule-based logic…
42	Vancomycin	`vancomycin`	Vancomycin Quality Checker — Glycopeptide Antibiotic (Ph. Eur., USP) ℹ️ The utility checks assay, CDP-1, residual protein, endotoxins, sterility. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL! CDP…
43	Levofloxacin	`levofloxacin`	Levofloxacin Quality Checker — Levofloxacin quality assessment (Ph.
44	Levofloxacin Optical Isomer Checker	`levofloxacin optical isomer checker`	Utility description: Levofloxacin Optical Isomer Checker Levofloxacin Optical Isomer Checker — Control of Levofloxacin Optical Isomerism ℹ️ Utility checks critical chiral purity parameters of levofloxacin: • Content of a…
45	Abacavir Sulfate	`abacavir sulfate`	Abacavir Sulfate Quality Checker — Abacavir sulfate quality assessment (BP/Ph.
46	Aciclovir	`aciclovir`	Aciclovir Quality Checker — Aciclovir quality assessment (BP/Ph.
47	Acyclovir	`acyclovir`	Acyclovir Quality Checker — Antiviral Agent (Ph. Eur., USP) ℹ️ The utility checks assay, related substances (<1.0%), acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICA…
48	Acyclovir Impurity Checker	`acyclovir impurity checker`	Utility description: Acyclovir Impurity Checker Acyclovir Impurity Checker — Acyclovir Impurity Control ℹ️ Utility checks critical quality parameters of acyclovir: • Assay (98.
49	Albendazole	`albendazole`	Albendazole Quality Checker — Albendazole quality assessment (BP/Ph.
50	Artemether Lumefantrine	`artemether lumefantrine`	Artemether Lumefantrine Quality Checker — Antimalarial Combo (WHO/Ph.
51	Artesunate	`artesunate`	Artesunate Quality Checker — Antimalarial Agent (Ph. Eur., WHO) ℹ️ The utility checks assay, specific rotation, DHA, moisture, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL! M…
52	Atazanavir Sulfate	`atazanavir sulfate`	Atazanavir Sulfate Quality Checker — Atazanavir sulfate quality assessment (BP/Ph.
53	Bictegravir Emtricitabine Tenofovir Alafenamide	`bictegravir emtricitabine tenofovir alafenamide`	Bictegravir Emtricitabine Tenofovir Alafenamide Quality Checker — Combo ART (HIV) ℹ️ The utility checks content of all 3 APIs, TAF hydrolysis, moisture, uniformity, synchronous dissolution.
54	Clotrimazole	`clotrimazole`	Clotrimazole Quality Checker — Clotrimazole quality assessment (Ph.
55	Daclatasvir Assay Checker	`daclatasvir assay checker`	Utility description: Daclatasvir Assay Checker Daclatasvir Assay Checker — Daclatasvir Quality Control ℹ️ Utility checks critical parameters of daclatasvir: • Assay (on dry basis) 98.
56	Dolutegravir	`dolutegravir`	Dolutegravir Quality Checker — Integrase Inhibitor (Ph. Eur., USP) ℹ️ The utility checks assay, oxidized impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️…
57	Efavirenz	`efavirenz`	Efavirenz Quality Checker — NNRTI (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!…
58	Emtricitabine Tenofovir Disoproxil Fumarate	`emtricitabine tenofovir disoproxil fumarate`	Emtricitabine Tenofovir Disoproxil Fumarate Quality Checker — Combo ART (HIV) ℹ️ The utility checks content of both APIs, emtricitabine sulfoxide, tenofovir (hydrolysis), moisture, synchronous dissolution.
59	Entecavir	`entecavir`	Entecavir Quality Checker — Antiviral (Nucleoside Analog) (Ph.
60	Fluconazole	`fluconazole`	Fluconazole Quality Checker — Fluconazole quality assessment (BP/Ph.
61	Fluconazole Related Substances Checker	`fluconazole related substances checker`	Utility description: Fluconazole Related Substances Checker Fluconazole Related Substances Checker — Fluconazole (Related Substances Control) ℹ️ Utility checks the impurity profile of Fluconazole API: • Assay (99.
62	Ganciclovir	`ganciclovir`	Ganciclovir Quality Checker — Ganciclovir quality assessment (BP/Ph.
63	Glecaprevir Pibrentasvir	`glecaprevir pibrentasvir`	Glecaprevir Pibrentasvir Quality Checker — Combo ART (HIV/HCV) ℹ️ The utility checks content of both APIs, specific impurities, synchronous dissolution.
64	Itraconazole	`itraconazole`	Itraconazole Quality Checker — Itraconazole quality assessment (Ph.
65	Ketoconazole	`ketoconazole`	Ketoconazole Quality Checker — Ketoconazole quality assessment (BP/Ph.
66	Lamivudine	`lamivudine`	Lamivudine Quality Checker — Lamivudine quality assessment (Ph.
67	Mebendazole	`mebendazole`	Mebendazole Quality Checker — Anthelmintic (Ph. Eur., USP) ℹ️ The utility checks assay, aminobenzimidazole, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL…
68	Miconazole	`miconazole`	Miconazole Quality Checker — Miconazole quality assessment (Ph.
69	Posaconazole	`posaconazole`	Posaconazole Quality Checker — Antifungal Agent (Ph. Eur., USP) ️ The utility checks assay, isomer/oxidized/hydrolysis impurities, toluene/acetonitrile/dichloromethane, dissolution profile. ℹ️ Does not use machine learni…
70	Ribavirin Purity Checker	`ribavirin purity checker`	Utility description: Ribavirin Purity Checker Ribavirin Purity Checker — Ribavirin Quality Control ℹ️ Utility checks critical quality parameters of ribavirin: • Assay content: 98.
71	Sofosbuvir Impurity Profiler	`sofosbuvir impurity profiler`	Utility description: Sofosbuvir Impurity Profiler Sofosbuvir Impurity Profiler — Sofosbuvir Impurity Profiling ℹ️ Utility checks critical purity parameters of sofosbuvir: • Assay content: 98.
72	Sofosbuvir Velpatasvir	`sofosbuvir velpatasvir`	Sofosbuvir/Velpatasvir Quality Checker — Combination Drug (Ph.
73	Valacyclovir	`valacyclovir`	Valacyclovir Quality Checker — Antiviral Agent (Ph. Eur., USP) ℹ️ The utility checks assay, acyclovir (hydrolysis), D-valine (isomer), methanol, dissolution profile. ℹ️ Does not use machine learning — rule-based logic on…
74	Valganciclovir	`valganciclovir`	Valganciclovir Quality Checker — Antiviral Agent (Ph. Eur., USP) ℹ️ The utility checks assay, ganciclovir (hydrolysis), D-valine (isomer), methanol, dissolution profile. ℹ️ Does not use machine learning — rule-based logi…
75	Voriconazole	`voriconazole`	Voriconazole Quality Checker — Voriconazole quality assessment (BP/Ph.
76	Zidovudine	`zidovudine`	Zidovudine Quality Checker — Zidovudine quality assessment (Ph.
77	Antibiotic Potency	`antibiotic potency evaluator`	Antibiotic Potency Evaluator — Оценка активности антибиотиков (Ph.
78	Antimicrobial Preservative Effectiveness	`antimicrobial preservative effectiveness checker`	Antimicrobial Preservative Effectiveness Checker — Preservative efficacy testing (Ph.
79	Automated Sterility Detection	`automated sterility detection`	Automated Sterility Detection Quality Checker — Evaluation of Automated Microbial Detection Systems ℹ️ Utility checks critical parameters of alternative sterility testing methods (USP , Ph.
80	Bacterial Endotoxins LAL	`bacterial endotoxins lalquality checker`	Bacterial Endotoxins LAL Quality Checker — Bacterial Endotoxin Testing (LAL Method) ℹ️ Utility checks critical parameters of the Bacterial Endotoxins Test (USP , Ph.
81	Bacterial Endotoxins Recombinant	`bacterial endotoxins recombinant`	Bacterial Endotoxins Recombinant Quality Checker — Control of Bacterial Endotoxins (Recombinant Method) ℹ️ Utility checks bacterial endotoxin content using recombinant Factor C (rFC) according to Ph.
82	Bacterial Endotoxin & Sterility Combined	`bacterial endotoxin and sterility combined`	Bacterial Endotoxin & Sterility Combined Quality Checker — Combined Safety Control for Vaccines ℹ️ Utility performs comprehensive verification of two critical safety parameters for parenteral vaccines according to Ph.
83	Bioburden	`bioburden checker`	Bioburden Checker — Microbial enumeration assessment (Ph. Eur. 2.6.12) ℹ️ The utility verifies that microbial enumeration test results comply with European Pharmacopoeia requirements. ℹ️ Does not use machine learning — r…
84	Bacterial Count Bioburden	`bacterial count bioburden checker`	Bacterial Count Bioburden Checker — Control of Microbial Bioburden ℹ️ Utility assesses the level of microbial bioburden in non-sterile pharmaceutical products according to Ph.
85	Bioburden Trend Checker	`bioburden trend checker`	Bioburden Trend Checker — evidence/process metrics checker for medical devices ℹ️ Utility performs deterministic review for 08_SterileMedicalDevicesSuite: • compliance score • traceability coverage • open critical/major…
86	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 W…
87	Endotoxin LAL	`endotoxin lal checker`	Endotoxin LAL Checker — Control of Bacterial Endotoxins (LAL Test) ℹ️ Utility checks bacterial endotoxin content using Limulus Amebocyte Lysate (LAL) according to Ph.
88	Endotoxin Biologic Product	`endotoxin biologic product`	Endotoxin Biologic Product Quality Checker — Control of Bacterial Endotoxins (BET) ℹ️ Utility checks critical parameters of Bacterial Endotoxins Test (USP / Ph.
89	Endotoxin Risk Predictor	`endotoxin risk predictor`	Project description
90	Endotoxins Assessor	`endotoxins assessor`	Endotoxins Assessor — Проверка содержания бактериальных эндотоксинов (Ph.
91	Environmental Monitoring Cleanroom	`environmental monitoring cleanroom`	Environmental Monitoring Cleanroom Quality Checker — Cleanroom Monitoring (EU GMP Annex 1) ℹ️ Utility checks environmental parameters compliance with EU GMP Annex 1 requirements: • Cleanliness Grades: A, B, C, D • Airbor…
92	Environmental Monitoring Trend	`environmental monitoring trend utility`	Environmental Monitoring Trend Utility — Environmental Monitoring Trend Analysis ℹ️ Utility performs statistical analysis of historical microbiological monitoring data (CFU) for production zones according to EU GMP Annex…
93	MAT Pyrogen	`mat pyrogen checker`	MAT Pyrogen Checker — Pyrogenicity assessment via Monocyte Activation Test (Ph.
94	Microbial Enumeration	`microbial enumeration checker`	Microbial Enumeration Checker — Total microbial count and pathogens (Ph.
95	Microbial Enumeration	`microbial enumeration evaluator`	Project description
96	Microbial Enumeration (TAMC/TYMC)	`microbial enumeration tamctymcquality checker`	Microbial Enumeration (TAMC/TYMC) Quality Checker — Control of Microbiological Quality ℹ️ Utility checks compliance of microbiological parameters with USP / Ph.
97	Microbial Identification System	`microbial identification system`	Microbial Identification System Quality Checker — Control of Microbial Identification Quality ℹ️ Utility checks reliability of microbial identification results (MALDI-TOF MS / Biochemical Systems): • Log Score (Confidenc…
98	Mycoplasma Contamination Forecaster	`mycoplasma contamination forecaster`	Project description
99	q PCR Viral Safety	`q pcr viral safety checker`	qPCR Viral Safety Checker — qPCR assay validation and interpretation (Ph.
100	Sterile Release Checklist	`sterile release checklist utility`	Sterile Release Checklist Utility — Sterile Batch Release Checklist ℹ️ Utility performs final verification of sterile pharmaceutical batch readiness for market release according to Annex 1 EU GMP and FDA Guidelines: • Mi…
101	Sterility & Mycoplasma Review	`sterility mycoplasma review utility`	Sterility & Mycoplasma Review Utility — Review of Sterility and Mycoplasma Tests ℹ️ Utility performs comprehensive verification of microbiological test results for biotechnological products according to Ph.
102	Sterility Test Review	`sterility test review utility`	Sterility Test Review Utility — Sterility Test Review ℹ️ Utility automates the verification of sterility test results according to Ph.
103	Water Microbiological	`water microbiological checker`	Water Microbiological Checker — Микробиологический контроль воды (Ph.
104	Water Microbiology	`water microbiology`	Water Microbiology Quality Checker — Control of Water Microbiological Purity ℹ️ Utility checks microbiological quality of Purified Water (PW) and Water for Injection (WFI) according to Ph.
105	Specified Microorganisms	`specified microorganisms`	Specified Microorganisms Quality Checker — Control of Specified Microorganisms ℹ️ Utility checks for the absence of pathogenic microorganisms in non-sterile pharmaceutical products according to Ph.
106	Pyrogen Test (Rabbit & MAT)	`pyrogen test rabbit matquality checker`	Pyrogen Test (Rabbit & MAT) Quality Checker — Control of Pyrogenicity ℹ️ Utility checks pyrogen test results according to USP and Ph.
107	Inactivated Vaccine Safety Test	`inactivated vaccine safety test`	Inactivated Vaccine Safety Test Quality Checker — Control of Inactivated Vaccine Safety (Inactivation Test) ℹ️ Utility assesses the completeness of pathogen inactivation in inactivated vaccines (IPV, Rabies, Influenza, E…
108	Live Attenuated Vaccine Genetic Stability	`live attenuated vaccine genetic stability`	Live Attenuated Vaccine Genetic Stability Quality Checker — Control of Genetic Stability of Live Attenuated Vaccines ℹ️ Utility analyzes sequencing data (NGS/Sanger) to confirm genetic stability of live attenuated vaccin…
109	mRNA Vaccine Integrity & LNP	`m rna vaccine integrity and lnp`	mRNA Vaccine Integrity & LNP Quality Checker — Control of mRNA Integrity and LNP Characteristics ℹ️ Utility assesses Critical Quality Attributes (CQA) of mRNA vaccines according to modern FDA, EMA, and ICH Q5A/Q6B guidel…
110	Replication Competent Virus RCV	`replication competent virus rcv`	Replication Competent Virus RCV Quality Checker — RCV Control in Gene Therapy ℹ️ Utility performs critical safety control of viral vectors, detecting presence of Replication Competent Viruses (RCV) according to FDA and E…
111	Residual Host Cell DNA	`residual host cell dna`	Residual Host Cell DNA Quality Checker — Control of Residual Host Cell DNA (qPCR) ℹ️ Utility assesses residual host cell DNA content in recombinant and culture-based vaccines according to WHO and FDA guidelines: • Critic…
112	Residual Host Cell DNA qPCR	`residual host cell dn aq pcr checker`	Residual Host Cell DNA qPCR Checker — Control of Residual Host Cell DNA (qPCR) ℹ️ Utility assesses residual host cell DNA content in recombinant and culture-based products according to WHO and FDA guidelines: • Critical…
113	Vaccine Potency TCID50/EID50	`vaccine potency tcid50 eid50`	Vaccine Potency TCID50/EID50 Quality Checker — Control of Vaccine Titer (TCID50 / EID50) ℹ️ Utility assesses the potency of live veterinary vaccines using Tissue Culture Infectious Dose (TCID50) or Egg Infectious Dose (E…
114	TCID50 Infectious Titer Calculator	`tcid50 infectious titer calculator`	TCID50 Infectious Titer Calculator — Infectious Titer Calculator (Spearman-Kärber) ℹ️ Utility calculates viral infectious titer (TCID50) using the Spearman-Kärber method, which is the standard for virological studies and…
115	Hemagglutination Titer	`hemagglutination titer checker`	Hemagglutination Titer Checker — Control of Hemagglutination Titer (HA) ℹ️ Utility assesses hemagglutinin activity in viral vaccines (mainly influenza) according to Ph.
116	Rabies Vaccine Potency Assay	`rabies vaccine potency assay reviewer`	Rabies Vaccine Potency Assay Reviewer — Rabies Vaccine Potency Test Review ℹ️ Utility performs automatic verification of acceptance criteria for rabies vaccine potency tests according to Ph.
117	Cold Chain Shipping Temperature And MKT	`cold chain shipping temperature and mkt`	Cold Chain Shipping Temperature And MKT Quality Checker — Temperature and MKT Analysis in Transport ℹ️ Utility performs deep analysis of temperature profiles during pharmaceutical cargo transportation according to USP an…
118	Cold Chain Excursion Decision	`cold chain excursion decision utility`	Cold Chain Excursion Decision Utility — Temperature Deviation Assessment ℹ️ Utility performs automated risk assessment for pharmaceutical batches exposed to non-standard temperatures (WHO TRS 953, USP ): • Freezing Detec…
119	Assay & Impurity HPLC	`assay impurity hplcquality checker`	Assay & Impurity HPLC Quality Checker — HPLC Assay and Related Substances Control ℹ️ Utility checks critical parameters of HPLC analysis (USP , Ph.
120	LC-MS Confirmation	`lcmsconfirmation`	LC-MS Confirmation Quality Checker — Structural Confirmation by LC-MS ℹ️ Utility checks critical parameters of substance identification by High Resolution Mass Spectrometry (HRMS): • Mass Error: ≤5.

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.

InfectiousDiseases AntiInfectives Antibiotics Antivirals Microbiology Sterility Endotoxins Vaccines CSV→JSON PackageArticle TherapeuticMapping

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

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