AssayImpurityHPLCQualityChecker

Assay & Impurity HPLC Quality Checker — HPLC Assay and Related Substances Control
ℹ️ Utility checks critical parameters of HPLC analysis (USP <621>, Ph. Eur. 2.2.46):
• Assay content (% on dried basis)
• Specific impurities (Impurity A, B etc., %)
• Total impurities (%)
• System suitability: Resolution of critical pair (Rs)
⚠️ CRITICAL: Exceeding impurity limits may indicate drug degradation or synthesis errors!
Low resolution (<2.0) invalidates the analysis according to pharmacopoeial requirements.
Usage:
AssayImpurityHPLCQualityChecker.exe → demo mode (console output)
AssayImpurityHPLCQualityChecker.exe input.csv output.json → evaluate your data
Input format:
BatchNumber,AssayPercent,ImpurityAPercent,ImpurityBPercent,TotalImpuritiesPercent,ResolutionCriticalPair
Example:
HPLC-API-2026-001,99.85,0.12,0.08,0.35,3.50
Supported analysis types:
• API Substance — control of Active Pharmaceutical Ingredients
• Finished Product — control of finished dosage forms (tablets, capsules, solutions)
• Degradation Study — monitoring degradation products in stability studies
— WHY IS THIS NEEDED?
HPLC is the gold standard for quantitative analysis in pharma:
• High selectivity allows separation of complex mixtures
• Sensitivity down to trace levels (ppm/ppb) for genotoxic impurity control
• Mandatory method for registration dossiers (CTD Module 3) in all major pharmacopoeias (USP, Ph. Eur., JP)
⚠️ CRITICAL:
• Assay: must strictly match label claim (typically 98.0–102.0% for substances). Deviations affect dosing!
• Impurities: each specific impurity has its own limit (e.g., NMT 0.5%). Total impurities are also limited (e.g., NMT 2.0%).
• Resolution: system suitability criterion. If peaks are not separated (Rs < 1.5–2.0), the result is unreliable.
• Tailing Factor: another important system suitability parameter (usually NMT 2.0) affecting integration accuracy.
Key features:
• Automatic check against pharmacopoeial limits (configurable per monograph)
• System suitability control (Resolution) before result evaluation
• Support for multiple specific impurities
• LIMS-compatible report generation (LabWare)
Critical parameters:
• Assay: 98.0 – 102.0 % (example for substance)
• Impurity A: NMT 0.50 %
• Impurity B: NMT 0.50 %
• Total Impurities: NMT 2.00 %
• Resolution: NLT 2.0
💡 Usage tips:
Ensure the chromatographic system passed System Suitability Test before running the utility.
Impurity limits must be taken from the current monograph (USP/Ph.Eur.) or registration dossier.
For gradient elution methods, pay special attention to Retention Time for peak identification.
If unknown peaks (>0.1%) are detected, their identification or safety justification (ICH Q3A/Q3B) is required.
⚠️ Note: This utility is basic for QC laboratories. It covers routine release control. For complex cases (genotoxic impurities, enantiomers), use specialized utilities (ResidualSolventsGCQualityChecker, ChiralPurityHPLCQualityChecker).