AceclofenacParacetamolQualityChecker

Aceclofenac Paracetamol

API assay biosimilars dissolution fixed-dose combinations generics heavy metals impurities

Aceclofenac Paracetamol Quality Checker — Combined Analgesic (Ph. Eur., USP)

ℹ️ The utility checks content of both APIs, toxic impurity PAP, specific aceclofenac impurities, dissolution.
ℹ️ Does not use machine learning — rule-based logic only.
⚠️ CRITICAL! p-Aminophenol (PAP) ≤ 0.005%. Synchronous dissolution of both components!

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

Input format:
BatchNumber,Aceclofenac_Content_Percent,Paracetamol_Content_Percent,Aceclofenac_Impurity_Diclofenac_Percent,Paracetamol_Impurity_PAP_Percent,Total_Impurities_Aceclofenac_Percent,Total_Impurities_Paracetamol_Percent,Dissolution_Aceclofenac_Percent,Dissolution_Paracetamol_Percent,Weight_Variation_RSD,Disintegration_Time_Min,Friability_Percent,Heavy_Metals_ppm,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected

Example:
ACE-PAR-2026-001,99.2,98.8,0.15,0.002,0.4,0.3,88.5,92.0,1.2,8.0,0.3,8,50,10,0,0

— WHY IS THIS NEEDED?
Aceclofenac (NSAID) + Paracetamol (analgesic) combination widely used for pain and inflammation:
• Requires simultaneous control of two Active Pharmaceutical Ingredients (APIs)
• Paracetamol has critical toxic impurity — p-Aminophenol (PAP), formed during synthesis or storage
• Aceclofenac may contain impurities of related diclofenac and other degradation products
• Important to ensure synchronous release of both components for rapid onset of action
⚠️ CRITICAL:
• Content of both APIs: 95–105% of label claim
• PAP (p-Aminophenol): ≤ 0.005% (50 ppm) — strictly controlled due to nephro- and hemato-toxicity
• Diclofenac impurity in aceclofenac: ≤ 0.5%
• Dissolution: ≥ 80% for both components within specified time (typically 30-45 min)
• Microbiology: absence of E.Coli and Salmonella, limits for TAMC/TYMC
• Heavy Metals: ≤ 20 ppm
⚠️ Note: Utility performs separate impurity analysis for each component but combines verdict. Exceeding PAP limit is absolute ground for batch rejection. Checking dissolution synchronicity is important: if one component releases fast and another slow, therapeutic effect may be compromised.

input.csv

BatchNumber,Aceclofenac_Content_Percent,Paracetamol_Content_Percent,Aceclofenac_Impurity_Diclofenac_Percent,Paracetamol_Impurity_PAP_Percent,Total_Impurities_Aceclofenac_Percent,Total_Impurities_Paracetamol_Percent,Dissolution_Aceclofenac_Percent,Dissolution_Paracetamol_Percent,Weight_Variation_RSD,Disintegration_Time_Min,Friability_Percent,Heavy_Metals_ppm,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
ACE-PAR-2026-001,99.2,98.8,0.15,0.002,0.4,0.3,88.5,92.0,1.2,8.0,0.3,8,50,10,0,0

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: AceclofenacParacetamolQualityCheckerAPI / object: Aceclofenac ParacetamolCategory: Global API

1. Scope

The Aceclofenac Paracetamol Quality Checker utility is used for Aceclofenac Paracetamol. 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, biosimilars, dissolution, fixed-dose combinations, generics, heavy metals, impurities, market map, microbiology

2. Execution modes

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

3. Key controlled areas

assay / content
purity and impurities
dissolution / disintegration
microbiology and pathogens
heavy metals / elemental impurities

4. Domain limits and critical parameters

⚠️ CRITICAL! p-Aminophenol (PAP) ≤ 0.005%. Synchronous dissolution of both components!
⚠️ CRITICAL:
Content of both APIs: 95–105% of label claim
PAP (p-Aminophenol): ≤ 0.005% (50 ppm) — strictly controlled due to nephro- and hemato-toxicity
Diclofenac impurity in aceclofenac: ≤ 0.5%
Dissolution: ≥ 80% for both components within specified time (typically 30-45 min)
Microbiology: absence of E.Coli and Salmonella, limits for TAMC/TYMC
Heavy Metals: ≤ 20 ppm
⚠️ Note: Utility performs separate impurity analysis for each component but combines verdict. Exceeding PAP limit is absolute ground for batch rejection. Checking dissolution synchronicity is important: if one component releases fast and another slow, therapeutic effect may be compromised.

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 Aceclofenac Paracetamol 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, dissolution / disintegration, microbiology and pathogens, heavy metals / elemental impurities.	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	`ACE-PAR-2026-001`	mandatory field; used for batch/lot traceability
2	`Aceclofenac_Content_Percent`	decimal	%	Aceclofenac Content %	`99.2`	numeric value; compared with assay/purity limit from specification or method
3	`Paracetamol_Content_Percent`	decimal	%	Paracetamol Content %	`98.8`	numeric value; compared with assay/purity limit from specification or method
4	`Aceclofenac_Impurity_Diclofenac_Percent`	decimal	%	Aceclofenac Impurity Diclofenac %	`0.15`	numeric value; compared with individual or total impurity limit
5	`Paracetamol_Impurity_PAP_Percent`	decimal	%	Paracetamol Impurity PAP %	`0.002`	numeric value; compared with individual or total impurity limit
6	`Total_Impurities_Aceclofenac_Percent`	decimal	%	Total Impurities Aceclofenac %	`0.4`	mandatory numeric value; rule comparison is performed by the utility
7	`Total_Impurities_Paracetamol_Percent`	decimal	%	Total Impurities Paracetamol %	`0.3`	mandatory numeric value; rule comparison is performed by the utility
8	`Dissolution_Aceclofenac_Percent`	decimal	%	Dissolution Aceclofenac %	`88.5`	numeric value; dissolution/disintegration profile checked according to method
9	`Dissolution_Paracetamol_Percent`	decimal	%	Dissolution Paracetamol %	`92.0`	numeric value; dissolution/disintegration profile checked according to method
10	`Weight_Variation_RSD`	decimal	as specified	Weight Variation RSD	`1.2`	mandatory numeric value; rule comparison is performed by the utility
11	`Disintegration_Time_Min`	decimal	min	Disintegration Time Min	`8.0`	numeric value; dissolution/disintegration profile checked according to method
12	`Friability_Percent`	decimal	%	Friability %	`0.3`	mandatory numeric value; rule comparison is performed by the utility
13	`Heavy_Metals_ppm`	decimal	ppm	Heavy Metals ppm	`8`	numeric value; checked as elemental/metal impurity
14	`Microbial_Count_TAMC`	decimal	as specified	Microbial Count TAMC	`50`	numeric value; compared with microbiological limits
15	`Microbial_Count_TYMC`	decimal	as specified	Microbial Count TYMC	`10`	numeric value; compared with microbiological limits
16	`EColi_Detected`	boolean / flag	0/1	EColi Detected	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent
17	`Salmonella_Detected`	boolean / flag	0/1	Salmonella Detected	`0`	valid flag required; prohibited organisms and growth are normally expected as 0 / absent

CSV example

BatchNumber,Aceclofenac_Content_Percent,Paracetamol_Content_Percent,Aceclofenac_Impurity_Diclofenac_Percent,Paracetamol_Impurity_PAP_Percent,Total_Impurities_Aceclofenac_Percent,Total_Impurities_Paracetamol_Percent,Dissolution_Aceclofenac_Percent,Dissolution_Paracetamol_Percent,Weight_Variation_RSD,Disintegration_Time_Min,Friability_Percent,Heavy_Metals_ppm,Microbial_Count_TAMC,Microbial_Count_TYMC,EColi_Detected,Salmonella_Detected
ACE-PAR-2026-001,99.2,98.8,0.15,0.002,0.4,0.3,88.5,92.0,1.2,8.0,0.3,8,50,10,0,0

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `AceclofenacParacetamolQualityChecker.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 Aceclofenac Paracetamol, 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": "AceclofenacParacetamolQualityChecker",
  "api": "Aceclofenac Paracetamol",
  "batchNumber": "ACE-PAR-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "ACE-PAR-2026-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Aceclofenac_Content_Percent",
      "value": "99.2",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Paracetamol_Content_Percent",
      "value": "98.8",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Aceclofenac_Impurity_Diclofenac_Percent",
      "value": "0.15",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Paracetamol_Impurity_PAP_Percent",
      "value": "0.002",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Total_Impurities_Aceclofenac_Percent",
      "value": "0.4",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Total_Impurities_Paracetamol_Percent",
      "value": "0.3",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Dissolution_Aceclofenac_Percent",
      "value": "88.5",
      "unit": "%",
      "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.
TC-006	Insufficient dissolution or excessive disintegration time	FAIL/WARNING is produced according to method criticality.

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

Global API & Biosimilars QC Suite

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

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Rheumatology QC Suite

QC package for rheumatology: NSAIDs, glucocorticoids, methotrexate, biologics and supporting impurity/potency checks.

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