Excipients_Sugars_Polyols_HPLC

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface, user requirements and functional behaviour of Excipients_Sugars_Polyols_HPLC. The utility is intended for automated verification of laboratory, pharmacopoeial, analytical or manufacturing QC parameters using input.csv and producing a structured output.json result.

Domain limits and critical parameters

• • Assay: usually 98.0–102.0%
• • Reducing Sugars: ≤0.5% (depends on substance)
• • Related Compounds (e.g., sorbitol in mannitol): ≤2.0%
• • Loss on Drying (LOD): specific for hydrates (e.g., lactose ~5%) or anhydrous forms
• • HPLC with Refractive Index Detector (RID) is the standard method for their analysis.
• • Control of related compounds is important as synthesis/hydrolysis processes may leave impurities (e.g., glucose in lactose, sorbitol in mannitol).
• • Reducing sugars can react with amine groups of active substances (Maillard reaction), causing discoloration and degradation.
• • Moisture is critical for dry granulation and direct compression processes.
• • Identification of excipient type is crucial for applying correct limits (e.g., LOD for lactose monohydrate ~5%, for mannitol <0.5%).
• • Reducing sugars must be minimal to prevent finished product instability.
• • Purity affects dosing and taste characteristics.
• • Adaptive limits based on substance type (Lactose, Mannitol, etc.).
• • Control of specific impurities (reducing sugars, polyol isomers).
• • Integration with HPLC-RID data.
• • Assay: 98.0-102.0% (Typical)
• • Reducing Sugars: <= 0.5% (Typical)

URS — User Requirements Specification

input.csv contract

BatchNumber,Type,Assay%,RedSugars%,Related%,LOD%
EXC-LAC-2026-001,Lactose_Monohydrate,99.5,0.1,0.2,4.8
EXC-MAN-2026-001,Mannitol,99.8,0.05,0.1,0.3
EXC-SOR-FAIL,Sorbitol,92.0,1.5,3.0,15.0

FS — Functional Specification

Example output.json

{
  "utilityId": "excipients-sugars-polyols-hplc",
  "utilityName": "Excipients_Sugars_Polyols_HPLC",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "EXC-LAC-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Type",
      "value": "Lactose_Monohydrate",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Assay%",
      "value": "99.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "RedSugars%",
      "value": "0.1",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Related%",
      "value": "0.2",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "LOD%",
      "value": "4.8",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "generatedFor": "QA/QC review and LIMS integration"
}

Traceability matrix

OQ/PQ test scenarios

QA/QC and change control

• Do not rename columns without updating the validator, documentation and test set.
• Retain input.csv, output.json, executable version, documentation and checksum.
• Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
• Critical limits must be verified against the approved specification, local SOPs and registration dossier.