Everolimus Residue Quantification Data for Cleaning Validation

Chromatographic data supports a validated UHPLC method for quantifying everolimus residues on pharmaceutical equipment surfaces. The method was developed by Jagdish Gohel using an Analytical Quality by Design framework and validated per ICH Q2 guidelines. The dataset was last updated in April 2026.

Use Cases

• Predict residue concentration from chromatographic retention time (1.57 min) and peak area using calibration data.
• Validate method linearity using the reported correlation coefficient (R² of 0.999) across the 0.4 to 3.0 μg/mL range.
• Assess method sensitivity by applying the reported limit of detection (0.100 μg/mL) and quantification (0.392 μg/mL).
• Compare precision and accuracy metrics like %RSD and recovery rates (91% to 100%) against in-house validation results.

Strengths

• Method validated per ICH Q2 (R2) guidelines with a high correlation coefficient of 0.999.
• Specific performance metrics provided, including LOD (0.100 μg/mL), LOQ (0.392 μg/mL), and recovery accuracy (91-100%).
• Chromatographic conditions are fully specified, including column type, mobile phase (65:35 acetonitrile:water), and flow rate (0.4 mL/min).

Limitations

• Dataset is small (1.3 MB), likely containing summary validation results rather than raw experimental runs.
• No raw sample data or column names are provided, limiting direct analysis of individual measurements.
• Temporal and geographic coverage of the underlying experiments is not specified.

Provenance

Source

Jagdish Gohel via figshare.

Collection Method

Data generated via a UHPLC method developed using Analytical Quality by Design, with risk assessment and central composite design.

Freshness

Last updated in April 2026.