BrimonidineTimolol_GlaucomaFDCQualityChecker
Brimonidine/Timolol Glaucoma FDC Quality Checker
Analgesic CSV→JSON ControlledSubstance FDC Glaucoma MissingAPI OTC Ophthalmology
Open selectionBrimonidine/Timolol Glaucoma FDC Quality Checker — Combination Eye Drop Quality Control
ℹ️ Utility checks critical parameters of combination eye drops:
• Brimonidine Assay: 90.0–110.0%
• Timolol Assay: 90.0–110.0%
• Impurities of each component: ≤1.0%
• Total Impurities: ≤2.0%
• pH: 5.6–6.6
• Osmolality: 250–350 mOsm/kg
• Sterility: Mandatory
• Preservative: 0.005–0.015%
• Particles: ≤10 per mL
⚠️ CRITICAL: Sterility violation is unacceptable for ophthalmic products.
pH and osmolality are critical for patient comfort and corneal safety.
Usage:
BrimonidineTimolol_GlaucomaFDCQualityChecker.exe → demo mode
BrimonidineTimolol_GlaucomaFDCQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,BrimonidineAssay,TimololAssay,BrimonidineImp,TimololImp,TotalImp,pH,Osmolality,Sterility,Preservative,Particles
Example (sterility: 0=sterile):
BT-EYE-2026-001,100.5,99.8,0.3,0.2,0.6,6.1,290.0,0,0.01,2.0
— WHY IS THIS NEEDED?
Brimonidine and timolol combination is used to lower intraocular pressure in glaucoma:
• Brimonidine — alpha-2 adrenergic agonist, reduces aqueous humor production
• Timolol — non-selective beta-blocker, reduces aqueous humor production
• Combination provides additive effect
• Ophthalmic products require strict control of sterility and physicochemical properties
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures therapeutic effect
• Impurities ≤1.0% for each component — degradation and synthesis products
• Total Impurities ≤2.0% — overall purity indicator
• pH 5.6–6.6 — critical for eye comfort and product stability
• Osmolality 250–350 mOsm/kg — isotonicity with tear fluid
• Sterility — mandatory to prevent eye infections
• Preservative (Benzalkonium Chloride) — prevents microbial growth after opening
• Particles — absence of visible particles is critical for corneal safety
Key features:
• Simultaneous check of two active substances with different mechanisms of action
• Control of physicochemical parameters specific to eye drops (pH, osmolality)
• Strict sterility and particle control
• Preservative content verification
Critical parameters:
• Brimonidine Assay: 90.0–110.0%
• Timolol Assay: 90.0–110.0%
• Brimonidine Impurities: ≤1.0%
• Timolol Impurities: ≤1.0%
• Total Impurities: ≤2.0%
• pH: 5.6–6.6
• Osmolality: 250–350 mOsm/kg
• Sterility: Sterile
• Preservative: 0.005–0.015%
• Particulate Matter: ≤10 count/mL
💡 Usage tips:
1. Assay determined by HPLC with UV detection
2. pH measured potentiometrically
3. Osmolality determined by cryoscopic method
4. Sterility checked by membrane filtration or direct inoculation
5. Particles controlled by light obscuration or microscopy
6. Store in light-protected place
⚠️ Note: Eye drops are sterile dosage forms contacting sensitive eye tissues. Any deviation in pH, osmolality, or presence of particles can cause severe irritation, pain, and corneal damage. Sterility is an absolute GMP requirement for this category of products.
ℹ️ Utility checks critical parameters of combination eye drops:
• Brimonidine Assay: 90.0–110.0%
• Timolol Assay: 90.0–110.0%
• Impurities of each component: ≤1.0%
• Total Impurities: ≤2.0%
• pH: 5.6–6.6
• Osmolality: 250–350 mOsm/kg
• Sterility: Mandatory
• Preservative: 0.005–0.015%
• Particles: ≤10 per mL
⚠️ CRITICAL: Sterility violation is unacceptable for ophthalmic products.
pH and osmolality are critical for patient comfort and corneal safety.
Usage:
BrimonidineTimolol_GlaucomaFDCQualityChecker.exe → demo mode
BrimonidineTimolol_GlaucomaFDCQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,BrimonidineAssay,TimololAssay,BrimonidineImp,TimololImp,TotalImp,pH,Osmolality,Sterility,Preservative,Particles
Example (sterility: 0=sterile):
BT-EYE-2026-001,100.5,99.8,0.3,0.2,0.6,6.1,290.0,0,0.01,2.0
— WHY IS THIS NEEDED?
Brimonidine and timolol combination is used to lower intraocular pressure in glaucoma:
• Brimonidine — alpha-2 adrenergic agonist, reduces aqueous humor production
• Timolol — non-selective beta-blocker, reduces aqueous humor production
• Combination provides additive effect
• Ophthalmic products require strict control of sterility and physicochemical properties
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures therapeutic effect
• Impurities ≤1.0% for each component — degradation and synthesis products
• Total Impurities ≤2.0% — overall purity indicator
• pH 5.6–6.6 — critical for eye comfort and product stability
• Osmolality 250–350 mOsm/kg — isotonicity with tear fluid
• Sterility — mandatory to prevent eye infections
• Preservative (Benzalkonium Chloride) — prevents microbial growth after opening
• Particles — absence of visible particles is critical for corneal safety
Key features:
• Simultaneous check of two active substances with different mechanisms of action
• Control of physicochemical parameters specific to eye drops (pH, osmolality)
• Strict sterility and particle control
• Preservative content verification
Critical parameters:
• Brimonidine Assay: 90.0–110.0%
• Timolol Assay: 90.0–110.0%
• Brimonidine Impurities: ≤1.0%
• Timolol Impurities: ≤1.0%
• Total Impurities: ≤2.0%
• pH: 5.6–6.6
• Osmolality: 250–350 mOsm/kg
• Sterility: Sterile
• Preservative: 0.005–0.015%
• Particulate Matter: ≤10 count/mL
💡 Usage tips:
1. Assay determined by HPLC with UV detection
2. pH measured potentiometrically
3. Osmolality determined by cryoscopic method
4. Sterility checked by membrane filtration or direct inoculation
5. Particles controlled by light obscuration or microscopy
6. Store in light-protected place
⚠️ Note: Eye drops are sterile dosage forms contacting sensitive eye tissues. Any deviation in pH, osmolality, or presence of particles can cause severe irritation, pain, and corneal damage. Sterility is an absolute GMP requirement for this category of products.
input.csv
BatchNumber,BrimonidineAssay,TimololAssay,BrimonidineImp,TimololImp,TotalImp,pH,Osmolality,Sterility,Preservative,Particles BT-EYE-2026-001,100.5,99.8,0.3,0.2,0.6,6.1,290.0,0,0.01,2.0 BT-EYE-2026-002,98.0,101.0,0.5,0.4,1.1,6.3,305.0,0,0.012,5.0
BrimonidineTimolol_GlaucomaFDCQualityChecker — Documentation
Bilingual RU/EN URS & FS. Source:
input.csv and *.description.txt. Package folder: Global/API coverage extension.Utility
BrimonidineTimolol_GlaucomaFDCQualityChecker
Package
Global/API coverage extension
CSV fields
11
Interface
CSV → JSON
Utility description
Brimonidine/Timolol Glaucoma FDC Quality Checker — Combination Eye Drop Quality Control
ℹ️ Utility checks critical parameters of combination eye drops:
• Brimonidine Assay: 90.0–110.0%
• Timolol Assay: 90.0–110.0%
• Impurities of each component: ≤1.0%
• Total Impurities: ≤2.0%
• pH: 5.6–6.6
• Osmolality: 250–350 mOsm/kg
• Sterility: Mandatory
• Preservative: 0.005–0.015%
• Particles: ≤10 per mL
⚠️ CRITICAL: Sterility violation is unacceptable for ophthalmic products.
pH and osmolality are critical for patient comfort and corneal safety.
Usage:
BrimonidineTimolol_GlaucomaFDCQualityChecker.exe → demo mode
BrimonidineTimolol_GlaucomaFDCQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,BrimonidineAssay,TimololAssay,BrimonidineImp,TimololImp,TotalImp,pH,Osmolality,Sterility,Preservative,Particles
Example (sterility: 0=sterile):
BT-EYE-2026-001,100.5,99.8,0.3,0.2,0.6,6.1,290.0,0,0.01,2.0
— WHY IS THIS NEEDED?
Brimonidine and timolol combination is used to lower intraocular pressure in glaucoma:
• Brimonidine — alpha-2 adrenergic agonist, reduces aqueous humor production
• Timolol — non-selective beta-blocker, reduces aqueous humor production
• Combination provides additive effect
• Ophthalmic products require strict control of sterility and physicochemical properties
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures therapeutic effect
• Impurities ≤1.0% for each component — degradation and synthesis products
• Total Impurities ≤2.0% — overall purity indicator
• pH 5.6–6.6 — critical for eye comfort and product stability
• Osmolality 250–350 mOsm/kg — isotonicity with tear fluid
• Sterility — mandatory to prevent eye infections
• Preservative (Benzalkonium Chloride) — prevents microbial growth after opening
• Particles — absence of visible particles is critical for corneal safety
Key features:
• Simultaneous check of two active substances with different mechanisms of action
• Control of physicochemical parameters specific to eye drops (pH, osmolality)
• Strict sterility and particle control
• Preservative content verification
Critical parameters:
• Brimonidine Assay: 90.0–110.0%
• Timolol Assay: 90.0–110.0%
• Brimonidine Impurities: ≤1.0%
• Timolol Impurities: ≤1.0%
• Total Impurities: ≤2.0%
• pH: 5.6–6.6
• Osmolality: 250–350 mOsm/kg
• Sterility: Sterile
• Preservative: 0.005–0.015%
• Particulate Matter: ≤10 count/mL
💡 Usage tips:
1. Assay determined by HPLC with UV detection
2. pH measured potentiometrically
3. Osmolality determined by cryoscopic method
4. Sterility checked by membrane filtration or direct inoculation
5. Particles controlled by light obscuration or microscopy
6. Store in light-protected place
⚠️ Note: Eye drops are sterile dosage forms contacting sensitive eye tissues. Any deviation in pH, osmolality, or presence of particles can cause severe irritation, pain, and corneal damage. Sterility is an absolute GMP requirement for this category of products.URS & FS — User Requirements and Functional Specification
This document describes the controlled interface and behaviour of BrimonidineTimolol_GlaucomaFDCQualityChecker for Brimonidine/Timolol Glaucoma FDC Quality Checker.
Portal packages
Global/API coverage extension, LabEx QC laboratory utilities, Lumex QC instrument utilities, Ophthalmology QC Suite, Toxicology QC Suite, World API/FDC extension
AnalgesicCSV→JSONControlledSubstanceFDCGlaucomaMissingAPIOTCOphthalmologyQCURS & FSP2Domain limits and critical parameters
Key fragments from the source description are shown below. Before production use, limits must be verified against the approved specification, registration dossier and local SOPs.
- ℹ️ Utility checks critical parameters of combination eye drops:
- • Brimonidine Assay: 90.0–110.0%
- • Timolol Assay: 90.0–110.0%
- • Impurities of each component: ≤1.0%
- • Total Impurities: ≤2.0%
- • Sterility: Mandatory
- • Particles: ≤10 per mL
- ⚠️ CRITICAL: Sterility violation is unacceptable for ophthalmic products.
- pH and osmolality are critical for patient comfort and corneal safety.
- BatchNumber,BrimonidineAssay,TimololAssay,BrimonidineImp,TimololImp,TotalImp,pH,Osmolality,Sterility,Preservative,Particles
- Example (sterility: 0=sterile):
- BT-EYE-2026-001,100.5,99.8,0.3,0.2,0.6,6.1,290.0,0,0.01,2.0
- • Ophthalmic products require strict control of sterility and physicochemical properties
- ⚠️ CRITICAL:
- • Assay 90.0–110.0% for each component — ensures therapeutic effect
- • Impurities ≤1.0% for each component — degradation and synthesis products
- • Total Impurities ≤2.0% — overall purity indicator
- • pH 5.6–6.6 — critical for eye comfort and product stability
URS — User Requirements Specification
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The utility shall accept an input.csv file for Brimonidine/Timolol Glaucoma FDC Quality Checker with headers defined in the data contract. | High | The file is processed without manual header editing. |
| URS-002 | The utility shall perform deterministic QC evaluation without machine learning and without probabilistic conformance decisions. | High | Identical input data, rule version and configuration produce reproducible results. |
| URS-003 | The utility shall validate mandatory fields, data types, ranges, units and domain plausibility. | High | Schema, conversion and range errors are explicitly reported. |
| URS-004 | The utility shall apply domain limits and rules from the description, approved specification, registration dossier and local SOPs. | High | Each check has PASS/WARNING/FAIL and a clear message. |
| URS-005 | The utility shall generate output.json with machine-readable results, source values, warnings, failures and critical findings. | High | JSON is suitable for LIMS/ELN/MES integration and QA/QC review. |
| URS-006 | The utility shall preserve traceability between batch/sample, input file, applied rules and final status. | High | Output contains identifiers, checked parameters and audit metadata. |
| URS-007 | The documentation shall support IQ/OQ/PQ, CSV/CSA and review by internal QA or inspectors. | Medium | URS, FS, input/output contract and test scenarios are supplied with the utility. |
| URS-008 | The utility shall be used as a QC decision-support tool and not as a substitute for approved specifications and QA/QP release decision. | Medium | Documentation states change control and limit-verification expectations. |
input.csv contract
| # | Field | Type | Sample | Purpose |
|---|---|---|---|---|
| 1 | BatchNumber | string / controlled vocabulary | BT-EYE-2026-001 | Batch or lot identifier used for traceability. |
| 2 | BrimonidineAssay | decimal | 100.5 | Quantitative content/potency; critical release parameter. |
| 3 | TimololAssay | decimal | 99.8 | Quantitative content/potency; critical release parameter. |
| 4 | BrimonidineImp | decimal | 0.3 | Controlled input parameter for deterministic QC rules. |
| 5 | TimololImp | decimal | 0.2 | Controlled input parameter for deterministic QC rules. |
| 6 | TotalImp | decimal | 0.6 | Controlled input parameter for deterministic QC rules. |
| 7 | pH | decimal | 6.1 | pH; parameter relevant to stability, compatibility and batch suitability. |
| 8 | Osmolality | decimal | 290.0 | Controlled input parameter for deterministic QC rules. |
| 9 | Sterility | decimal | 0 | Microbiological/endotoxin parameter relevant to safety. |
| 10 | Preservative | decimal | 0.01 | Controlled input parameter for deterministic QC rules. |
| 11 | Particles | decimal | 2.0 | Size/particle attribute; physicochemical quality parameter. |
BatchNumber,BrimonidineAssay,TimololAssay,BrimonidineImp,TimololImp,TotalImp,pH,Osmolality,Sterility,Preservative,Particles BT-EYE-2026-001,100.5,99.8,0.3,0.2,0.6,6.1,290.0,0,0.01,2.0 BT-EYE-2026-002,98.0,101.0,0.5,0.4,1.1,6.3,305.0,0,0.012,5.0
Input validation rules
| ID | Field | Rule | Criticality |
|---|---|---|---|
| VR-001 | BatchNumber | The field shall match an approved dictionary or accepted string representation. | High |
| VR-002 | BrimonidineAssay | The value shall be numeric, non-empty and domain-plausible for the approved specification. | High |
| VR-003 | TimololAssay | The value shall be numeric, non-empty and domain-plausible for the approved specification. | High |
| VR-004 | BrimonidineImp | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-005 | TimololImp | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-006 | TotalImp | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-007 | pH | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-008 | Osmolality | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-009 | Sterility | The value shall be numeric, non-empty and domain-plausible for the approved specification. | High |
| VR-010 | Preservative | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
| VR-011 | Particles | The value shall be numeric, non-empty and domain-plausible for the approved specification. | Medium |
FS — Functional Specification
| ID | Function | Implementation |
|---|---|---|
| FS-001 | CLI execution | Support execution modes: demo mode without arguments and production mode input.csv output.json. |
| FS-002 | CSV import | Read input.csv in UTF-8/CSV-compatible format and validate header and expected columns. |
| FS-003 | Schema validation | Check mandatory fields, column count, unknown key fields and empty mandatory values. |
| FS-004 | Type conversion | Convert numeric, flag and text values; invalid format is recorded as a row-level error. |
| FS-005 | Domain rule engine | Apply rules for Brimonidine/Timolol Glaucoma FDC Quality Checker, including critical limits from the description and approved specification. |
| FS-006 | Status aggregation | Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance. |
| FS-007 | JSON export | Write output.json with detailed checks, source values, warnings, failures and critical findings. |
| FS-008 | Audit support | Keep result structure suitable for review, deviation investigation and calculation reproduction. |
| FS-009 | Integration contract | Support the scenario LIMS/ELN/MES → input.csv → utility → output.json → portal/admin review. |
| FS-010 | Fallback mapping | If the combined utility is not deployed, use component checks: timolol-quality-checker, brimonidine-quality-checker plus generic Lumex/LabEx checks. |
| FS-011 | Error handling | Return explicit messages for missing file, empty CSV, invalid schema, output write failure and invalid format. |
Example output.json
{
"utilityId": "brimonidine-timolol-glaucoma-fdc-quality-checker",
"utilityFolder": "BrimonidineTimolol_GlaucomaFDCQualityChecker",
"package": "Global/API coverage extension",
"overallStatus": "PASS|WARNING|FAIL",
"sourceFile": "input.csv",
"processedAtUtc": "2026-07-02T00:00:00Z",
"checks": [
{
"parameter": "BatchNumber",
"value": "BT-EYE-2026-001",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-001"
},
{
"parameter": "BrimonidineAssay",
"value": "100.5",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-002"
},
{
"parameter": "TimololAssay",
"value": "99.8",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-003"
},
{
"parameter": "BrimonidineImp",
"value": "0.3",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-004"
},
{
"parameter": "TimololImp",
"value": "0.2",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-005"
},
{
"parameter": "TotalImp",
"value": "0.6",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-006"
},
{
"parameter": "pH",
"value": "6.1",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-007"
},
{
"parameter": "Osmolality",
"value": "290.0",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-008"
},
{
"parameter": "Sterility",
"value": "0",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-009"
},
{
"parameter": "Preservative",
"value": "0.01",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-010"
},
{
"parameter": "Particles",
"value": "2.0",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-011"
}
],
"criticalFindings": [],
"warnings": [],
"audit": {
"inputHash": "sha256:<calculated at runtime>",
"rulesVersion": "<utility executable version>",
"documentation": "BrimonidineTimolol_GlaucomaFDCQualityChecker.documentation.html"
}
}
Traceability matrix
| URS | FS | Test | Evidence |
|---|---|---|---|
| URS-001 | FS-001, FS-002 | OQ-001 | Verify execution and import of valid input.csv. |
| URS-002 | FS-005, FS-006 | OQ-004 | Repeat the same dataset and compare output.json. |
| URS-003 | FS-003, FS-004, FS-011 | OQ-002, OQ-003 | Verify missing columns and invalid types. |
| URS-004 | FS-005, FS-006 | OQ-004, PQ-001 | Verify critical deviations on real/boundary data. |
| URS-005 | FS-007, FS-009 | OQ-005 | Verify JSON schema and downstream-system suitability. |
| URS-006 | FS-008 | OQ-006 | Verify identifiers and audit metadata. |
| URS-007 | FS-008, FS-011 | IQ-001, OQ-007 | Verify documentation completeness and control evidence. |
| URS-008 | FS-005, FS-008, FS-010 | PQ-002 | Verify review workflow and no replacement of QA decision. |
IQ/OQ/PQ test scenarios
| ID | Scenario | Expected result |
|---|---|---|
| IQ-001 | Verify executable, input.csv, documentation and checksum availability. | Delivery set is complete; version is recorded. |
| OQ-001 | Valid sample row from input.csv. | PASS or acceptable WARNING according to rules. |
| OQ-002 | Remove a mandatory CSV column. | Schema error or FAIL with missing-column reference. |
| OQ-003 | Place a non-numeric value into a numeric field. | Type-conversion error with row/field reference. |
| OQ-004 | Set a critical parameter outside the limit. | FAIL and critical finding. |
| OQ-005 | Verify output.json structure. | All mandatory sections are present and JSON is valid. |
| OQ-006 | Verify batch/sample traceability. | Input and result identifiers match. |
| OQ-007 | Verify fallback/decomposition for combined APIs. | Component checks are explicitly documented. |
| PQ-001 | Verify 3–5 real user batches/samples. | Result is confirmed by QC/QA review. |
| PQ-002 | Verify deviation workflow and manual QA decision. | Utility supports review but does not replace approved decision. |
QA/QC and change control
- Do not rename columns without updating validator, documentation and test set.
- Retain input.csv, output.json, executable version and checksum.
- Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
- Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
- For combination products, document whether the specialized FDC utility or fallback component checks were used.
- The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.
Included in packages
Global API & Biosimilars QC Suite
Package for high-demand global APIs, generics and biosimilars, including fixed-dose combinations and biological products.
OpenOphthalmology QC Suite
QC package for ophthalmology: eye drops, antiglaucoma agents, antibiotics, sterile solutions, osmolality, pH, particles and preservatives.
OpenToxicology QC Suite
QC utility package for toxicologically relevant risks: genotoxic impurities, residual solvents, elemental impurities, heavy metals, mercury, mycotoxins, pesticides, extractables/leachables and degradation impurities.
OpenWorld API Extension QC Suite
Extended package for 130 additional high-demand APIs and biological products prepared as a market-coverage backlog.
Open