Article: ENT QC Suite

QC package for ENT: nasal sprays, ear drops, local antiseptics, corticosteroids, antibiotics and upper-airway medicines.

Package purpose

QC package for ENT: nasal sprays, ear drops, local antiseptics, corticosteroids, antibiotics and upper-airway medicines.

Utility count: 1277. 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	AAS Elemental Impurities Class 2A	`aas elemental impurities class2 a`	Utility description: AAS Elemental Impurities Class 2A AAS Elemental Impurities Class 2A — Class 2A Elements Control (ICH Q3D) ℹ️ Utility checks Class 2A elemental impurities according to ICH Q3D: • Cobalt (Co) ≤5.
2	Antimicrobial Preservative Effectiveness	`antimicrobial preservative effectiveness checker`	Antimicrobial Preservative Effectiveness Checker — Preservative efficacy testing (Ph.
3	Azelastine Hydrochloride	`azelastine hydrochloride`	Azelastine Hydrochloride Quality Checker — Azelastine hydrochloride quality assessment (BP/Ph.
4	Beclometasone Dipropionate	`beclometasone dipropionate`	Beclometasone Dipropionate Quality Checker — Beclometasone dipropionate quality assessment (BP/Ph.
5	Benzalkonium Chloride	`benzalkonium chloride`	Benzalkonium Chloride Quality Checker — Benzalkonium Chloride (Antiseptic, Preservative) (Ph.
6	Budesonide	`budesonide`	Budesonide Quality Checker — Glucocorticosteroid (Ph.
7	Budesonide Formoterol	`budesonide formoterol`	Budesonide Formoterol Quality Checker — Inhalation Product (Ph.
8	Delivered Dose Uniformity Inhaler	`delivered dose uniformity inhaler`	Delivered Dose Uniformity Inhaler Quality Checker — Delivered Dose Uniformity of Inhalers ℹ️ Utility checks critical parameters of Delivered Dose Uniformity (DDU) per USP : • Mean delivered dose: 80–120% of Label Claim (LC) • Relative Stand…
9	Desloratadine	`desloratadine`	Desloratadine Quality Checker — Desloratadine quality assessment (BP/Ph.
10	Elemental Impurities ICP	`elemental impurities icpquality checker`	Elemental Impurities ICP Quality Checker — Control of Elemental Impurities (ICP-MS/OES) ℹ️ Utility checks critical parameters of toxic element content according to ICH Q3D: • Class 1 (Cd, Pb, As, Hg): Strict control due to high toxicity • C…
11	Fluticasone Propionate	`fluticasone propionate`	Fluticasone Propionate Quality Checker — Fluticasone propionate quality assessment (Ph.
12	Fluticasone Propionate Nasal	`fluticasone propionate nasal`	Fluticasone Propionate Nasal Quality Checker — Nasal Spray (Ph.
13	Fluticasone Salmeterol	`fluticasone salmeterol`	Fluticasone Salmeterol Quality Checker — Combo Inhaler (ICS + LABA) (Ph.
14	I131 Volatility Extended	`i131 volatility extended checker`	I-131 Volatility Extended Checker — Extended volatile iodine control in iodine-131 capsules ℹ️ Utility performs DEEP analysis of volatile iodine with: • Current value check (≤5.
15	Inhalation APSD	`inhalation apsdquality checker`	Inhalation APSD Quality Checker — Control of Aerodynamic Particle Size Distribution (APSD) ℹ️ Utility checks critical parameters of inhaler aerosol cloud (USP / Ph.
16	Inhalation Particle Assessor	`inhalation particle assessor`	Inhalation Particle Assessor — Оценка аэродинамических характеристик ингаляций (Ph.
17	Ipratropium	`ipratropium`	Ipratropium Quality Checker — Anticholinergic (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized impurities, chloroform, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
18	Mometasone	`mometasone`	Mometasone Quality Checker — Glucocorticosteroid (Ph.
19	Montelukast	`montelukast`	Montelukast Quality Checker — Leukotriene Receptor Antagonist (Ph.
20	Montelukast Levocetirizine	`montelukast levocetirizine`	Montelukast Levocetirizine Quality Checker — Combo Product (Asthma/Allergy) ℹ️ The utility checks content of both APIs, montelukast sulfoxide, dextrocetirizine, moisture, uniformity.
21	Neomycin Sulfate	`neomycin sulfate`	Neomycin Sulfate Quality Checker — Neomycin sulfate quality assessment (BP/Ph.
22	Osmolality	`osmolality`	Osmolality Quality Checker — Control of Solution Osmolality ℹ️ Utility checks compliance of osmolality with specified limits (USP / Ph.
23	Salbutamol	`salbutamol`	Salbutamol Quality Checker — Bronchodilator (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, salbutamol ketone, toluene, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
24	Tiotropium Bromide Monohydrate	`tiotropium bromide monohydrate`	Tiotropium Bromide Monohydrate Quality Checker — Tiotropium bromide monohydrate quality assessment (Ph.
25	Umeclidinium	`umeclidinium`	Umeclidinium Quality Checker — Antimuscarinic Agent (Ph.
26	Vilanterol	`vilanterol`	Vilanterol Quality Checker — Beta2-Agonist (LABA) (Ph.
27	Viscosity & Rheology	`viscosity rheology`	Viscosity & Rheology Quality Checker — Control of Viscosity and Rheology ℹ️ Utility assesses rheological parameters of pharmaceutical liquids, gels, and ointments according to USP : • Dynamic Viscosity (cP or mPa·s) — resistance to flow • S…
28	Xylometazoline	`xylometazoline`	Xylometazoline Quality Checker — Nasal Decongestant (Ph.