AspirinAtorvastatinRamiprilPolypillQualityChecker
Aspirin/Atorvastatin/Ramipril Polypill Quality Checker
Antihypertensive CSV→JSON Cardiology FDC Lipid-lowering MissingAPI P1 Polypill
Open selectionAspirin/Atorvastatin/Ramipril Polypill Quality Checker — Cardiovascular Polypill Quality Control
ℹ️ Utility checks critical parameters of triple combination (ASA + Statin + ACEi):
• Assay of each component: 90.0–110.0%
• Salicylic Acid (aspirin degradation): ≤3.0%
• Atorvastatin/Ramipril Impurities: ≤1.5%
• Total Impurities: ≤4.0%
• Dissolution of each component: ≥85% (Q)
• Moisture Content: ≤4.0% (STRICT!)
• Heavy Metals: ≤20 ppm
⚠️ CRITICAL: Aspirin easily hydrolyzes to salicylic acid in humid environments.
Ramipril and atorvastatin are also moisture-sensitive. Moisture limit reduced to 4.0%.
Usage:
AspirinAtorvastatinRamiprilPolypillQualityChecker.exe → demo mode
AspirinAtorvastatinRamiprilPolypillQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,AspirinAssayPercent,AtorvastatinAssayPercent,RamiprilAssayPercent,SalicylicAcidPercent,AtorvastatinImpurityPercent,RamiprilImpurityPercent,TotalImpuritiesPercent,DissolutionAspirinPercent,DissolutionAtorvastatinPercent,DissolutionRamiprilPercent,MoistureContentPercent,HeavyMetalsPPM
Example:
POLY-CV-2026-001,99.5,100.2,99.8,1.2,0.6,0.5,2.5,95.0,92.0,93.5,2.8,4.0
— WHY IS THIS NEEDED?
Polypill (aspirin + atorvastatin + ramipril) is used for secondary prevention of cardiovascular diseases:
• Aspirin — antiplatelet agent, prevents thrombosis
• Atorvastatin — statin, lowers LDL cholesterol
• Ramipril — ACE inhibitor, lowers BP and cardiac remodeling
• Combination improves treatment adherence (one tablet instead of three)
• All three components are chemically incompatible with moisture
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures cardioprotection
• Salicylic Acid ≤3.0% — main marker of aspirin degradation (hydrolysis)
• Atorvastatin and Ramipril impurities ≤1.5% — oxidation and hydrolysis products
• Total Impurities ≤4.0% — higher limit allowed due to formulation complexity
• Dissolution ≥85% for each component — ensures bioavailability
• Moisture Content ≤4.0% — CRITICAL! Standard 5% may be excessive for aspirin
• Heavy Metals ≤20 ppm — drug safety
Key features:
• Specific control of salicylic acid as aspirin stability indicator
• Strict moisture limit (4.0%) to protect all three components
• Individual impurity control for statin and ACE inhibitor
• Comprehensive dissolution assessment of three substances with different solubility
Critical parameters:
• Aspirin Assay: 90.0–110.0%
• Atorvastatin Assay: 90.0–110.0%
• Ramipril Assay: 90.0–110.0%
• Salicylic Acid: ≤3.0%
• Atorvastatin Impurities: ≤1.5%
• Ramipril Impurities: ≤1.5%
• Total Impurities: ≤4.0%
• Dissolution (each): ≥85% (Q)
• Moisture Content: ≤4.0%
• Heavy Metals: ≤20 ppm
💡 Usage tips:
1. Salicylic acid determined by HPLC simultaneously with aspirin
2. Atorvastatin is light and oxidation sensitive — use protection during sample prep
3. Ramipril may form diketopiperazine derivatives upon heating
4. Moisture determined by Karl Fischer method (LOD may give high results due to volatile degradation products)
5. Store in airtight packaging with desiccant, avoid high temperatures
6. If salicylic acid increases, batch should be rejected even if aspirin assay is within spec
⚠️ Note: Polypills containing aspirin present a special technological challenge. Acetylsalicylic acid is an ester and is unstable in the presence of water, alkalis, and certain excipients (e.g., magnesium stearate). Combined with hygroscopic ramipril and atorvastatin, the risk of cross-degradation increases. Moisture control is the primary tool for ensuring shelf life.
ℹ️ Utility checks critical parameters of triple combination (ASA + Statin + ACEi):
• Assay of each component: 90.0–110.0%
• Salicylic Acid (aspirin degradation): ≤3.0%
• Atorvastatin/Ramipril Impurities: ≤1.5%
• Total Impurities: ≤4.0%
• Dissolution of each component: ≥85% (Q)
• Moisture Content: ≤4.0% (STRICT!)
• Heavy Metals: ≤20 ppm
⚠️ CRITICAL: Aspirin easily hydrolyzes to salicylic acid in humid environments.
Ramipril and atorvastatin are also moisture-sensitive. Moisture limit reduced to 4.0%.
Usage:
AspirinAtorvastatinRamiprilPolypillQualityChecker.exe → demo mode
AspirinAtorvastatinRamiprilPolypillQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,AspirinAssayPercent,AtorvastatinAssayPercent,RamiprilAssayPercent,SalicylicAcidPercent,AtorvastatinImpurityPercent,RamiprilImpurityPercent,TotalImpuritiesPercent,DissolutionAspirinPercent,DissolutionAtorvastatinPercent,DissolutionRamiprilPercent,MoistureContentPercent,HeavyMetalsPPM
Example:
POLY-CV-2026-001,99.5,100.2,99.8,1.2,0.6,0.5,2.5,95.0,92.0,93.5,2.8,4.0
— WHY IS THIS NEEDED?
Polypill (aspirin + atorvastatin + ramipril) is used for secondary prevention of cardiovascular diseases:
• Aspirin — antiplatelet agent, prevents thrombosis
• Atorvastatin — statin, lowers LDL cholesterol
• Ramipril — ACE inhibitor, lowers BP and cardiac remodeling
• Combination improves treatment adherence (one tablet instead of three)
• All three components are chemically incompatible with moisture
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures cardioprotection
• Salicylic Acid ≤3.0% — main marker of aspirin degradation (hydrolysis)
• Atorvastatin and Ramipril impurities ≤1.5% — oxidation and hydrolysis products
• Total Impurities ≤4.0% — higher limit allowed due to formulation complexity
• Dissolution ≥85% for each component — ensures bioavailability
• Moisture Content ≤4.0% — CRITICAL! Standard 5% may be excessive for aspirin
• Heavy Metals ≤20 ppm — drug safety
Key features:
• Specific control of salicylic acid as aspirin stability indicator
• Strict moisture limit (4.0%) to protect all three components
• Individual impurity control for statin and ACE inhibitor
• Comprehensive dissolution assessment of three substances with different solubility
Critical parameters:
• Aspirin Assay: 90.0–110.0%
• Atorvastatin Assay: 90.0–110.0%
• Ramipril Assay: 90.0–110.0%
• Salicylic Acid: ≤3.0%
• Atorvastatin Impurities: ≤1.5%
• Ramipril Impurities: ≤1.5%
• Total Impurities: ≤4.0%
• Dissolution (each): ≥85% (Q)
• Moisture Content: ≤4.0%
• Heavy Metals: ≤20 ppm
💡 Usage tips:
1. Salicylic acid determined by HPLC simultaneously with aspirin
2. Atorvastatin is light and oxidation sensitive — use protection during sample prep
3. Ramipril may form diketopiperazine derivatives upon heating
4. Moisture determined by Karl Fischer method (LOD may give high results due to volatile degradation products)
5. Store in airtight packaging with desiccant, avoid high temperatures
6. If salicylic acid increases, batch should be rejected even if aspirin assay is within spec
⚠️ Note: Polypills containing aspirin present a special technological challenge. Acetylsalicylic acid is an ester and is unstable in the presence of water, alkalis, and certain excipients (e.g., magnesium stearate). Combined with hygroscopic ramipril and atorvastatin, the risk of cross-degradation increases. Moisture control is the primary tool for ensuring shelf life.
input.csv
id,val
AspirinAtorvastatinRamiprilPolypillQualityChecker — Documentation
Bilingual RU/EN URS & FS. Source:
input.csv and *.description.txt. Package folder: Cardiology QC Suite.Utility
AspirinAtorvastatinRamiprilPolypillQualityChecker
Package
Cardiology QC Suite
CSV fields
2
Interface
CSV → JSON
Utility description
Aspirin/Atorvastatin/Ramipril Polypill Quality Checker — Cardiovascular Polypill Quality Control
ℹ️ Utility checks critical parameters of triple combination (ASA + Statin + ACEi):
• Assay of each component: 90.0–110.0%
• Salicylic Acid (aspirin degradation): ≤3.0%
• Atorvastatin/Ramipril Impurities: ≤1.5%
• Total Impurities: ≤4.0%
• Dissolution of each component: ≥85% (Q)
• Moisture Content: ≤4.0% (STRICT!)
• Heavy Metals: ≤20 ppm
⚠️ CRITICAL: Aspirin easily hydrolyzes to salicylic acid in humid environments.
Ramipril and atorvastatin are also moisture-sensitive. Moisture limit reduced to 4.0%.
Usage:
AspirinAtorvastatinRamiprilPolypillQualityChecker.exe → demo mode
AspirinAtorvastatinRamiprilPolypillQualityChecker.exe input.csv output.json → evaluate data
Input format:
BatchNumber,AspirinAssayPercent,AtorvastatinAssayPercent,RamiprilAssayPercent,SalicylicAcidPercent,AtorvastatinImpurityPercent,RamiprilImpurityPercent,TotalImpuritiesPercent,DissolutionAspirinPercent,DissolutionAtorvastatinPercent,DissolutionRamiprilPercent,MoistureContentPercent,HeavyMetalsPPM
Example:
POLY-CV-2026-001,99.5,100.2,99.8,1.2,0.6,0.5,2.5,95.0,92.0,93.5,2.8,4.0
— WHY IS THIS NEEDED?
Polypill (aspirin + atorvastatin + ramipril) is used for secondary prevention of cardiovascular diseases:
• Aspirin — antiplatelet agent, prevents thrombosis
• Atorvastatin — statin, lowers LDL cholesterol
• Ramipril — ACE inhibitor, lowers BP and cardiac remodeling
• Combination improves treatment adherence (one tablet instead of three)
• All three components are chemically incompatible with moisture
⚠️ CRITICAL:
• Assay 90.0–110.0% for each component — ensures cardioprotection
• Salicylic Acid ≤3.0% — main marker of aspirin degradation (hydrolysis)
• Atorvastatin and Ramipril impurities ≤1.5% — oxidation and hydrolysis products
• Total Impurities ≤4.0% — higher limit allowed due to formulation complexity
• Dissolution ≥85% for each component — ensures bioavailability
• Moisture Content ≤4.0% — CRITICAL! Standard 5% may be excessive for aspirin
• Heavy Metals ≤20 ppm — drug safety
Key features:
• Specific control of salicylic acid as aspirin stability indicator
• Strict moisture limit (4.0%) to protect all three components
• Individual impurity control for statin and ACE inhibitor
• Comprehensive dissolution assessment of three substances with different solubility
Critical parameters:
• Aspirin Assay: 90.0–110.0%
• Atorvastatin Assay: 90.0–110.0%
• Ramipril Assay: 90.0–110.0%
• Salicylic Acid: ≤3.0%
• Atorvastatin Impurities: ≤1.5%
• Ramipril Impurities: ≤1.5%
• Total Impurities: ≤4.0%
• Dissolution (each): ≥85% (Q)
• Moisture Content: ≤4.0%
• Heavy Metals: ≤20 ppm
💡 Usage tips:
1. Salicylic acid determined by HPLC simultaneously with aspirin
2. Atorvastatin is light and oxidation sensitive — use protection during sample prep
3. Ramipril may form diketopiperazine derivatives upon heating
4. Moisture determined by Karl Fischer method (LOD may give high results due to volatile degradation products)
5. Store in airtight packaging with desiccant, avoid high temperatures
6. If salicylic acid increases, batch should be rejected even if aspirin assay is within spec
⚠️ Note: Polypills containing aspirin present a special technological challenge. Acetylsalicylic acid is an ester and is unstable in the presence of water, alkalis, and certain excipients (e.g., magnesium stearate). Combined with hygroscopic ramipril and atorvastatin, the risk of cross-degradation increases. Moisture control is the primary tool for ensuring shelf life.URS & FS — User Requirements and Functional Specification
This document describes the controlled interface and behaviour of AspirinAtorvastatinRamiprilPolypillQualityChecker for Aspirin/Atorvastatin/Ramipril Polypill Quality Checker.
Portal packages
Cardiology QC Suite, Global/API coverage extension, LabEx QC laboratory utilities, Lumex QC instrument utilities, World API/FDC extension
AntihypertensiveCSV→JSONCardiologyFDCLipid-loweringMissingAPIPolypillQCURS & FSP1Domain 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 triple combination (ASA + Statin + ACEi):
- • Assay of each component: 90.0–110.0%
- • Salicylic Acid (aspirin degradation): ≤3.0%
- • Atorvastatin/Ramipril Impurities: ≤1.5%
- • Total Impurities: ≤4.0%
- • Dissolution of each component: ≥85% (Q)
- • Moisture Content: ≤4.0% (STRICT!)
- • Heavy Metals: ≤20 ppm
- ⚠️ CRITICAL: Aspirin easily hydrolyzes to salicylic acid in humid environments.
- Ramipril and atorvastatin are also moisture-sensitive. Moisture limit reduced to 4.0%.
- BatchNumber,AspirinAssayPercent,AtorvastatinAssayPercent,RamiprilAssayPercent,SalicylicAcidPercent,AtorvastatinImpurityPercent,RamiprilImpurityPercent,TotalImpuritiesPercent,DissolutionAspirinPercent,DissolutionAtorvastatinPercent,DissolutionRamiprilPercent,MoistureContentPercent,HeavyMetalsPPM
- ⚠️ CRITICAL:
- • Assay 90.0–110.0% for each component — ensures cardioprotection
- • Salicylic Acid ≤3.0% — main marker of aspirin degradation (hydrolysis)
- • Atorvastatin and Ramipril impurities ≤1.5% — oxidation and hydrolysis products
- • Total Impurities ≤4.0% — higher limit allowed due to formulation complexity
- • Dissolution ≥85% for each component — ensures bioavailability
- • Moisture Content ≤4.0% — CRITICAL! Standard 5% may be excessive for aspirin
URS — User Requirements Specification
| ID | Requirement | Criticality | Acceptance criterion |
|---|---|---|---|
| URS-001 | The utility shall accept an input.csv file for Aspirin/Atorvastatin/Ramipril Polypill 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 | id | string / controlled vocabulary | | Controlled input parameter for deterministic QC rules. |
| 2 | val | string / controlled vocabulary | | Controlled input parameter for deterministic QC rules. |
id,val
Input validation rules
| ID | Field | Rule | Criticality |
|---|---|---|---|
| VR-001 | id | The field shall match an approved dictionary or accepted string representation. | High |
| VR-002 | val | The field shall match an approved dictionary or accepted string representation. | High |
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 Aspirin/Atorvastatin/Ramipril Polypill 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: aspirin-quality-checker, atorvastatin-quality-checker, ramipril-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": "aspirin-atorvastatin-ramipril-polypill-quality-checker",
"utilityFolder": "AspirinAtorvastatinRamiprilPolypillQualityChecker",
"package": "Cardiology QC Suite",
"overallStatus": "PASS|WARNING|FAIL",
"sourceFile": "input.csv",
"processedAtUtc": "2026-07-02T00:00:00Z",
"checks": [
{
"parameter": "id",
"value": "",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-001"
},
{
"parameter": "val",
"value": "",
"status": "PASS|WARNING|FAIL",
"message": "Deterministic rule-based check result",
"ruleReference": "FS-RULE-002"
}
],
"criticalFindings": [],
"warnings": [],
"audit": {
"inputHash": "sha256:<calculated at runtime>",
"rulesVersion": "<utility executable version>",
"documentation": "AspirinAtorvastatinRamiprilPolypillQualityChecker.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
Cardiology QC Suite
QC package for cardiology medicines: antihypertensives, anticoagulants, antiplatelets, lipid-lowering and antiarrhythmic medicines plus supporting QC checks.
OpenGlobal API & Biosimilars QC Suite
Package for high-demand global APIs, generics and biosimilars, including fixed-dose combinations and biological products.
OpenWorld API Extension QC Suite
Extended package for 130 additional high-demand APIs and biological products prepared as a market-coverage backlog.
Open