FluticasonePropionateNasalQualityChecker

Fluticasone Propionate Nasal

API assay biologics biosimilars fixed-dose combinations generics impurities market map

Fluticasone Propionate Nasal Quality Checker — Nasal Spray (Ph. Eur., USP)

ℹ️ The utility checks particle size (D90), dose uniformity after idle, absence of Pseudomonas/Staph.
ℹ️ Does not use machine learning — rule-based logic only.
⚠️ CRITICAL! D90 ≤10 µm, Absence of Pseudomonas/Staph, Dose after idle 80-120%!

Usage:
FluticasonePropionateNasalQualityChecker.exe → demo mode
FluticasonePropionateNasalQualityChecker.exe input.csv output.json → evaluate data

Input format:
BatchNumber,Assay_Percent,Impurity_A_Percent,Impurity_B_Percent,Total_Impurities_Percent,pH_Value,Particle_Size_D50_um,Particle_Size_D90_um,Large_Particles_Percent,Dose_Uniformity_First_Spray_Percent,Dose_Uniformity_After_Idle_Percent,Spray_Pattern_Width_mm,Plume_Geometry_Deviation,Preservative_Content_Percent,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected,Pseudomonas_Aeruginosa_Detected,Staphylococcus_Aureus_Detected

Example:
FLU-NAS-2026-001,98.5,0.15,0.05,0.25,5.5,3.5,8.0,1.2,95.0,92.0,45.0,2.0,0.01,10,2,0,0,0,0

— WHY IS THIS NEEDED?
Fluticasone Propionate Nasal Spray — suspension for topical use:
• Particle size critical: Too large particles (>10 µm) cause mucosal irritation, sandy sensation, and post-nasal drip. Too small may reach lungs.
• Dose Uniformity after Idle: Patients use spray intermittently. Product must deliver accurate dose even after 7 days idle without shaking (or minimal shaking).
• Microbiology: Product is non-sterile but must have strict limits. Presence of Pseudomonas aeruginosa and Staphylococcus aureus is unacceptable as they are major nasal pathogens causing severe infections.
• Spray Pattern: Plume geometry affects deposition in nasal turbinate.
⚠️ CRITICAL:
• Assay: 90–110% of label claim
• Particle Size D90: ≤ 10.0 µm (strict limit for comfort)
• Dose Uniformity (after idle): 80–120%
• Pseudomonas aeruginosa: Absence in 1 g/mL
• Staphylococcus aureus: Absence in 1 g/mL
• TAMC: ≤ 100 CFU/mL (stricter than oral)
• Impurity A (Free Acid): ≤ 0.5% (hydrolysis product)
⚠️ Note: Utility focuses on nasal suspension specifics. Particle size control performed by laser diffraction or microscopy. "Dose after idle" test simulates real patient usage. Microbiological control includes specific pathogens for ENT organs. Preservative (if present) must be in active range.

input.csv

BatchNumber,Assay_Percent,Impurity_A_Percent,Impurity_B_Percent,Total_Impurities_Percent,pH_Value,Particle_Size_D50_um,Particle_Size_D90_um,Large_Particles_Percent,Dose_Uniformity_First_Spray_Percent,Dose_Uniformity_After_Idle_Percent,Spray_Pattern_Width_mm,Plume_Geometry_Deviation,Preservative_Content_Percent,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected,Pseudomonas_Aeruginosa_Detected,Staphylococcus_Aureus_Detected
FLU-NAS-2026-001,98.5,0.15,0.05,0.25,5.5,3.5,8.0,1.2,95.0,92.0,45.0,2.0,0.01,10,2,0,0,0,0

URS & FS — user requirements and functional specification

This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.

Utility: FluticasonePropionateNasalQualityCheckerAPI / object: Fluticasone Propionate NasalCategory: Global API

1. Scope

The Fluticasone Propionate Nasal Quality Checker utility is used for Fluticasone Propionate Nasal. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.

The utility does not use machine learning; decisions are produced by deterministic rules.

Categories: Global API

Tags: API, assay, biologics, biosimilars, fixed-dose combinations, generics, impurities, market map, microbiology, sterility, uniformity

2. Execution modes

FluticasonePropionateNasalQualityChecker.exe                            → demo mode
FluticasonePropionateNasalQualityChecker.exe input.csv output.json      → evaluate data

3. Key controlled areas

assay / content
purity and impurities
microbiology and pathogens
pH and physicochemical parameters

4. Domain limits and critical parameters

⚠️ CRITICAL! D90 ≤10 µm, Absence of Pseudomonas/Staph, Dose after idle 80-120%!
Particle size critical: Too large particles (>10 µm) cause mucosal irritation, sandy sensation, and post-nasal drip. Too small may reach lungs.
Dose Uniformity after Idle: Patients use spray intermittently. Product must deliver accurate dose even after 7 days idle without shaking (or minimal shaking).
Microbiology: Product is non-sterile but must have strict limits. Presence of Pseudomonas aeruginosa and Staphylococcus aureus is unacceptable as they are major nasal pathogens causing severe infections.
Spray Pattern: Plume geometry affects deposition in nasal turbinate.
⚠️ CRITICAL:
Assay: 90–110% of label claim
Particle Size D90: ≤ 10.0 µm (strict limit for comfort)
Dose Uniformity (after idle): 80–120%
Pseudomonas aeruginosa: Absence in 1 g/mL
Staphylococcus aureus: Absence in 1 g/mL
TAMC: ≤ 100 CFU/mL (stricter than oral)
Impurity A (Free Acid): ≤ 0.5% (hydrolysis product)
⚠️ Note: Utility focuses on nasal suspension specifics. Particle size control performed by laser diffraction or microscopy. "Dose after idle" test simulates real patient usage. Microbiological control includes specific pathogens for ENT organs. Preservative (if present) must be in active range.

Limits stated in the description must be verified against the current approved specification, pharmacopoeial monograph and registration dossier before production use.

5. URS — user requirements

ID	Requirement	Criticality	Acceptance criterion
URS-001	The system shall accept an `input.csv` file for Fluticasone Propionate Nasal with the exact columns listed in the “Input data contract” section.	High	A file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error.
URS-002	The system shall support execution without arguments in demo mode and execution with `input.csv output.json` for user data.	Medium	Both execution scenarios produce a predictable result or clear diagnostic error.
URS-003	The system shall perform rule-based controls for: assay / content, purity and impurities, microbiology and pathogens, pH and physicochemical parameters.	High	Each controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML.
URS-004	The system shall preserve traceability between batch/lot, source values, applied rules and final verdict.	High	Output includes batch identifier, source values, parameter statuses and critical findings.
URS-005	The system shall generate machine-readable `output.json` for LIMS/ELN/MES, batch record and QA/QC review.	High	JSON contains overall status, check array, warnings, failures and source-file reference.
URS-006	The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks.	High	The document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval.
URS-007	The system shall clearly separate technical data errors from specification nonconformities.	Medium	Schema/type errors are not mixed with pharmacopoeial deviations and are reported separately.

6. input.csv data contract

The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.

#	Column	Type	Unit	Description	Sample	Control rule
1	`BatchNumber`	identifier	as specified	Batch Number	`FLU-NAS-2026-001`	mandatory field; used for batch/lot traceability
2	`Assay_Percent`	decimal	%	Assay %	`98.5`	numeric value; compared with assay/purity limit from specification or method
3	`Impurity_A_Percent`	decimal	%	Impurity A %	`0.15`	numeric value; compared with individual or total impurity limit
4	`Impurity_B_Percent`	decimal	%	Impurity B %	`0.05`	numeric value; compared with individual or total impurity limit
5	`Total_Impurities_Percent`	decimal	%	Total Impurities %	`0.25`	mandatory numeric value; rule comparison is performed by the utility
6	`pH_Value`	decimal	pH	p H Value	`5.5`	mandatory numeric value; rule comparison is performed by the utility
7	`Particle_Size_D50_um`	decimal	µm	Particle Size D50 um	`3.5`	mandatory numeric value; rule comparison is performed by the utility
8	`Particle_Size_D90_um`	decimal	µm	Particle Size D90 um	`8.0`	mandatory numeric value; rule comparison is performed by the utility
9	`Large_Particles_Percent`	decimal	%	Large Particles %	`1.2`	mandatory numeric value; rule comparison is performed by the utility
10	`Dose_Uniformity_First_Spray_Percent`	decimal	%	Dose Uniformity First Spray %	`95.0`	mandatory numeric value; rule comparison is performed by the utility
11	`Dose_Uniformity_After_Idle_Percent`	decimal	%	Dose Uniformity After Idle %	`92.0`	mandatory numeric value; rule comparison is performed by the utility
12	`Spray_Pattern_Width_mm`	decimal	as specified	Spray Pattern Width mm	`45.0`	mandatory numeric value; rule comparison is performed by the utility
13	`Plume_Geometry_Deviation`	decimal	as specified	Plume Geometry Deviation	`2.0`	mandatory numeric value; rule comparison is performed by the utility
14	`Preservative_Content_Percent`	decimal	%	Preservative Content %	`0.01`	numeric value; compared with assay/purity limit from specification or method
15	`Microbial_Count_TAMC`	decimal	as specified	Microbial Count TAMC	`10`	numeric value; compared with microbiological limits
16	`Microbial_Count_TYMC`	decimal	as specified	Microbial Count TYMC	`2`	numeric value; compared with microbiological limits
17	`EColi_Detected`	boolean / flag	0/1	EColi Detected	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent
18	`Salmonella_Detected`	boolean / flag	0/1	Salmonella Detected	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent
19	`Pseudomonas_Aeruginosa_Detected`	boolean / flag	0/1	Pseudomonas Aeruginosa Detected	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent
20	`Staphylococcus_Aureus_Detected`	boolean / flag	0/1	Staphylococcus Aureus Detected	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent

CSV example

BatchNumber,Assay_Percent,Impurity_A_Percent,Impurity_B_Percent,Total_Impurities_Percent,pH_Value,Particle_Size_D50_um,Particle_Size_D90_um,Large_Particles_Percent,Dose_Uniformity_First_Spray_Percent,Dose_Uniformity_After_Idle_Percent,Spray_Pattern_Width_mm,Plume_Geometry_Deviation,Preservative_Content_Percent,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected,Pseudomonas_Aeruginosa_Detected,Staphylococcus_Aureus_Detected
FLU-NAS-2026-001,98.5,0.15,0.05,0.25,5.5,3.5,8.0,1.2,95.0,92.0,45.0,2.0,0.01,10,2,0,0,0,0

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `FluticasonePropionateNasalQualityChecker.exe` supports demo mode and `input.csv output.json` processing mode.
FS-002	CSV parser	The import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator.
FS-003	Field conversion	Each column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag.
FS-004	Domain rule engine	For Fluticasone Propionate Nasal, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check.
FS-005	Criticality handling	Critical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS.
FS-006	JSON writer	`output.json` stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages.
FS-007	Integration contract	The CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service.
FS-008	Error handling	Schema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS.

8. output.json contract

The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.

{
  "utility": "FluticasonePropionateNasalQualityChecker",
  "api": "Fluticasone Propionate Nasal",
  "batchNumber": "FLU-NAS-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "FLU-NAS-2026-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Assay_Percent",
      "value": "98.5",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Impurity_A_Percent",
      "value": "0.15",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Impurity_B_Percent",
      "value": "0.05",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Total_Impurities_Percent",
      "value": "0.25",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "pH_Value",
      "value": "5.5",
      "unit": "pH",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Particle_Size_D50_um",
      "value": "3.5",
      "unit": "µm",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Particle_Size_D90_um",
      "value": "8.0",
      "unit": "µm",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "sourceFile": "input.csv"
}

9. OQ/PQ test scenarios

ID	Scenario	Expected result
TC-001	Valid CSV with expected header and sample row	All rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail.
TC-002	A mandatory input.csv column is missing	Import is rejected or the row receives FAIL with schema reference.
TC-003	A numeric field contains text or a blank value	Type conversion error is recorded; the result is not hidden as PASS.
TC-004	A parameter is outside specification or critical limit	Critical parameters produce FAIL; non-critical deviations produce WARNING according to the rule.
TC-005	Positive pathogen/microbiological flag or microbiological limit excursion	Critical FAIL is produced with the offending parameter.

10. QA/QC, CSV and change control

Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
Column names must not be changed without updating the validator and test scenarios.
The source CSV, output.json and utility version should be stored together as an evidence package.
Any change in control rules must go through change control and repeated OQ scenario verification.

Included in packages

ENT QC Suite

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

Open

Global API & Biosimilars QC Suite

Package for high-demand global APIs, generics and biosimilars, including fixed-dose combinations and biological products.

Open