Purity, Recovery & Endotoxin Calculator
Calculate area purity, simple or matrix-spike recovery, and dose-based endotoxin values.
Purity, recovery & endotoxin results
Choose a mode and enter values.
Area normalization cannot assume equal detector response factors across components. Review integration, co-elution, wavelength, and response factors separately.
Sources: ICH Q2(R2) Validation of Analytical Procedures; FDA Bacterial Endotoxins/Pyrogens.
Tool Guide
Definition
Purity, Recovery & Endotoxin Calculator — Three modes calculate (1) main-peak over total-area purity, (2) simple output/input or matrix-spike net recovery, and (3) endotoxin exposure plus the K/M concentration limit from measured EU/mL and maximum one-hour dose.
Purpose
(1) Cross-check chromatogram area normalization (2) Keep process recovery separate from analytical spike recovery (3) Convert EU/mL to dose exposure in EU/kg (4) Prepare K/M and arithmetic tolerance-use values
How to Use
① Choose Purity, Recovery, or Endotoxin. ② Enter numerator and denominator values in common units for that mode. ③ For endotoxin, confirm the K and maximum one-hour mL/kg dose applicable to the product. ④ Copy the calculated values. This tool does not replace detector-response correction, analytical-method validation, compendial method suitability, or release decisions.
Examples
Purity example) main=950, total=1,000 → 95% Spike recovery example) spiked=11, unspiked=2, added=10 → 90% Endotoxin example) measured=0.2 EU/mL, M=10 mL/kg, K=5 EU/kg → exposure=2 EU/kg, K/M=0.5 EU/mL, tolerance used=40% Only arithmetic direction is reported; no automatic acceptance decision is made.