NaproxenQualityChecker
Naproxen
Naproxen Quality Checker — Naproxen quality assessment (Ph. Eur. 0495)
ℹ️ The utility verifies that key parameters of naproxen comply with European Pharmacopoeia requirements.
ℹ️ Does not use machine learning — rule-based logic only.
⚠️ 6-O-Desmethylnaproxen impurity ≤0.1%. Water content ≤0.5%. Appearance must be white.
Usage:
NaproxenQualityChecker.exe → demo mode (console output)
NaproxenQualityChecker.exe input.csv output.json → evaluate your data
Input format:
ProductName,BatchNumber,Appearance,Assay_percent,DesmethylNaproxen_percent,WaterContent_percent,MeltingRangeCelsius
Example:
Naproxen_API,B20250514,WhiteOrAlmostWhiteCrystallinePowder,99.5,0.08,0.3,"DecomposesAbove190"
— WHY IS THIS NEEDED?
Naproxen contains a methoxy group on the naphthyl ring, prone to demethylation under light and oxidants, forming 6-O-desmethylnaproxen, which:
• Has reduced anti-inflammatory activity,
• May reduce therapeutic efficacy,
• Indicates API degradation during storage without light protection.
Compliance with Ph. Eur. 0495 is mandatory for NSAID drug release.
input.csv
ProductName,BatchNumber,Appearance,Assay_percent,DesmethylNaproxen_percent,WaterContent_percent,MeltingRangeCelsius Naproxen_API,B20250514,WhiteOrAlmostWhiteCrystallinePowder,99.5,0.08,0.3,"DecomposesAbove190"
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.
1. Scope
The Naproxen Quality Checker utility is used for Naproxen. 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: BP monographs
Tags: API, assay, British Pharmacopoeia, impurities, monographs, specification, water quality
2. Execution modes
NaproxenQualityChecker.exe → demo mode (console output) NaproxenQualityChecker.exe input.csv output.json → evaluate your data
3. Key controlled areas
- assay / content
- pH and physicochemical parameters
4. Domain limits and critical parameters
- ⚠️ 6-O-Desmethylnaproxen impurity ≤0.1%. Water content ≤0.5%. Appearance must be white.
5. URS — user requirements
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The system shall accept an input.csv file for Naproxen 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, 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 | ProductName | identifier | as specified | Product Name | Naproxen_API | mandatory value; format and acceptability are checked by the utility |
| 2 | BatchNumber | identifier | as specified | Batch Number | B20250514 | mandatory field; used for batch/lot traceability |
| 3 | Appearance | text | as specified | Appearance | WhiteOrAlmostWhiteCrystallinePowder | mandatory value; format and acceptability are checked by the utility |
| 4 | Assay_percent | decimal | % | Assay percent | 99.5 | numeric value; compared with assay/purity limit from specification or method |
| 5 | DesmethylNaproxen_percent | decimal | % | Desmethyl Naproxen percent | 0.08 | mandatory numeric value; rule comparison is performed by the utility |
| 6 | WaterContent_percent | decimal | % | Water Content percent | 0.3 | numeric value; compared with assay/purity limit from specification or method |
| 7 | MeltingRangeCelsius | decimal | °C | Melting Range Celsius | DecomposesAbove190 | mandatory value; format and acceptability are checked by the utility |
CSV example
ProductName,BatchNumber,Appearance,Assay_percent,DesmethylNaproxen_percent,WaterContent_percent,MeltingRangeCelsius Naproxen_API,B20250514,WhiteOrAlmostWhiteCrystallinePowder,99.5,0.08,0.3,"DecomposesAbove190"
7. FS — functional specification
| ID | Function | Implementation description |
|---|---|---|
| FS-001 | CLI entry point | The executable NaproxenQualityChecker.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 Naproxen, 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": "NaproxenQualityChecker",
"api": "Naproxen",
"batchNumber": "B20250514",
"overallStatus": "PASS|WARNING|FAIL",
"checkedAtUtc": "2026-05-18T00:00:00Z",
"checks": [
{
"parameter": "ProductName",
"value": "Naproxen_API",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "BatchNumber",
"value": "B20250514",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "Appearance",
"value": "WhiteOrAlmostWhiteCrystallinePowder",
"unit": "as specified",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "Assay_percent",
"value": "99.5",
"unit": "%",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "DesmethylNaproxen_percent",
"value": "0.08",
"unit": "%",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "WaterContent_percent",
"value": "0.3",
"unit": "%",
"status": "PASS|WARNING|FAIL",
"message": "Rule-based check result"
},
{
"parameter": "MeltingRangeCelsius",
"value": "DecomposesAbove190",
"unit": "°C",
"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. |
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
Algeria: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenArgentina: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenAustralia: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenBangladesh: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenBrazil: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenBritish Pharmacopoeia Monographs QC Suite
Utility package for British Pharmacopoeia monographs covering drug substances, APIs and finished products.
OpenCanada: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenChina: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenColombia: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenDemocratic Republic of the Congo: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenEgypt: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenEthiopia: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenFrance: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenGermany: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenIndia: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenIndonesia: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenIran: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenItaly: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenJapan: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenKenya: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenMexico: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenMyanmar: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenNigeria: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenPakistan: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenPhilippines: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenRheumatology QC Suite
QC package for rheumatology: NSAIDs, glucocorticoids, methotrexate, biologics and supporting impurity/potency checks.
OpenRussia: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenSaudi Arabia: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenSouth Africa: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenSouth Korea: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenSudan: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenTanzania: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenThailand: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenTurkey: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenUganda: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenUnited Kingdom: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenUnited States: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
OpenVietnam: national essential medicines QC package
QC utility package aligned with the country essential/reimbursed medicines list analogue and cross-checked against WHO EML. Only utilities already present in the portal are included; the package is a validation/discussion starting map, not an official registry copy.
Open