Article: Proctology QC Suite

QC package for proctology: local anaesthetics, corticosteroids, anti-inflammatory, anti-infective and supporting medicines for rectal dosage forms.

Package purpose

QC package for proctology: local anaesthetics, corticosteroids, anti-inflammatory, anti-infective and supporting medicines for rectal dosage forms.

Utility count: 22. The package is intended for QC laboratories, QA, CSV and LIMS/ELN/MES integration.

Data

Typical flow: instrument or LIMS creates input.csv, the utility performs rule-based checks and returns output.json.

Validation

Each utility is supported by URS/FS and scenarios that can be used for IQ/OQ/PQ preparation.

Licensing

Licensing can be discussed as an as-is legal-entity licence without resale rights, a LIMS/ELN/MES integration module, or a pilot package for a production site/laboratory. Representative contacts are rendered from the portal configuration.

Utilities and checked parameters

#	API / product	Utility	Key checks
1	Anesthetic Lidocaine In Filler	`anesthetic lidocaine in filler checker`	Anesthetic Lidocaine in Filler Quality Checker — Dermal Fillers with Lidocaine (ISO 13485, EU MDR) ℹ️ The utility checks lidocaine content, uniformity of distribution, toxic impurities (2,6-dimethylaniline), pH, sterility, endotoxins.
2	Betamethasone	`betamethasone`	Betamethasone Quality Checker — Betamethasone quality assessment (BP/Ph.
3	Bisacodyl	`bisacodyl`	Bisacodyl Quality Checker — Bisacodyl quality assessment (BP/Ph.
4	Calcium Hydroxylapatite	`calcium hydroxylapatite`	Calcium Hydroxylapatite Quality Checker — Calcium Hydroxylapatite (CaHA) Dermal Fillers (Radiesse type) (ISO 13485, EU MDR) ℹ️ The utility checks CaHA content, microsphere size, agglomerates presence, carrier gel rheology, extrusion force,…
5	Clotrimazole	`clotrimazole`	Clotrimazole Quality Checker — Clotrimazole quality assessment (Ph.
6	Gallium68 FAPI	`gallium68 fapiquality checker`	Gallium-68 FAPI Quality Checker — ⁶⁸Ga-FAPI for PET imaging of tumor stroma ℹ️ Utility checks quality of FAPI (Fibroblast Activation Protein Inhibitor) radiopharmaceutical: • Specific activity (≥50 GBq/μmol) • Radiochemical purity (≥95%) •…
7	Hydrocortisone	`hydrocortisone`	Hydrocortisone Quality Checker — Hydrocortisone quality assessment (Ph.
8	Irinotecan Hydrochloride Trihydrate	`irinotecan hydrochloride trihydrate`	Irinotecan Hydrochloride Trihydrate Quality Checker — Irinotecan hydrochloride trihydrate quality assessment (BP/Ph.
9	Mesalazine	`mesalazine`	Mesalazine Quality Checker — Anti-inflammatory Agent (Ph.
10	Methylprednisolone	`methylprednisolone`	Methylprednisolone Quality Checker — Methylprednisolone quality assessment (Ph.
11	Metronidazole	`metronidazole`	Metronidazole Quality Checker — Metronidazole quality assessment (Ph.
12	Microbiological	`microbiological`	Microbiological Quality Checker — Проверка микробиологического качества (Ph.
13	Nitroglycerin	`nitroglycerin`	Nitroglycerin Quality Checker — Vasodilator (Ph. Eur., USP) ️ The utility checks assay, dinitrates/mononitrates (hydrolysis), rapid release. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
14	Nonoxynol9	`nonoxynol9`	Nonoxynol-9 Quality Checker — Nonoxynol-9 (Spermicidal Surfactant) (Ph.
15	Oxaliplatin	`oxaliplatin`	Oxaliplatin Quality Checker — Oxaliplatin quality assessment (BP/Ph.
16	Panitumumab	`panitumumab`	Panitumumab Quality Checker — Biologic Drug (Anti-EGFR mAb) (Ph.
17	Prednisolone	`prednisolone`	Prednisolone Quality Checker — Glucocorticosteroid (Ph.
18	Residue On Ignition	`residue on ignition checker`	Residue on Ignition Checker — Inorganic residue verification (Ph.
19	InfraLUM ID Fluconazole	`infra lum id fluconazole`	Utility description: InfraLUM ID Fluconazole InfraLUM ID Fluconazole — Fluconazole Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
20	Polyethylene Glycol Impurity Checker	`polyethylene glycol impurity checker`	Utility description: Polyethylene Glycol Impurity Checker Polyethylene Glycol Impurity Checker — Control of Polyethylene Glycol (PEG) Impurities ℹ️ Utility checks critical safety parameters of PEG: • Ethylene Glycol: ≤10 ppm • Diethylene Gl…
21	Density & Refractive Index	`density refractive index`	Density & Refractive Index Quality Checker — Control of Density and Refractive Index ℹ️ Utility checks critical physical parameters of liquid substances: • Density: within ±0.
22	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.